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Trial record 52 of 1254 for:    ASPIRIN AND Platelet Aggregation

A Study of the Onset and Offset of Antiplatelet Effects Comparing Ticagrelor, Clopidogrel, and Placebo With Aspirin

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ClinicalTrials.gov Identifier: NCT00528411
Recruitment Status : Completed
First Posted : September 12, 2007
Results First Posted : January 11, 2012
Last Update Posted : January 13, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Coronary Artery Disease
Interventions Drug: Ticagrelor Tablets
Drug: Clopidogrel (over encapsulated) capsule
Drug: Aspirin Tablets
Enrollment 123
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ticagrelor Clopidogrel Placebo
Hide Arm/Group Description Ticagrelor 180 mg loading dose followed by 90 mg Twice Daily (bd), plus clopidogrel placebo loading and Once Daily (od) maintenance doses Clopidogrel 600 mg loading dose followed by 75 mg Twice Daily (od), plus ticagrelor placebo loading and Once Daily (bd) maintenance doses Ticagrelor 180 mg placebo loading dose followed by 90 mg Twice Daily (bd), plus clopidogrel placebo loading and Once Daily (od) maintenance doses
Period Title: Overall Study
Started 57 54 12
Completed 52 51 11
Not Completed 5 3 1
Reason Not Completed
Adverse Event             4             0             1
Incorrect Enrolment             1             1             0
Severe non-compliance to protocol             0             1             0
Prior commitment medication             0             1             0
Arm/Group Title Ticagrelor Clopidogrel Placebo Total
Hide Arm/Group Description Ticagrelor 180 mg loading dose followed by 90 mg bd, plus Clopidogrel placebo loading and od maintenance doses Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses Total of all reporting groups
Overall Number of Baseline Participants 57 54 12 123
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Year
Number Analyzed 57 participants 54 participants 12 participants 123 participants
62.2  (9.10) 65.4  (7.98) 63.9  (8.32) 63.8  (8.62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 54 participants 12 participants 123 participants
Female
14
  24.6%
14
  25.9%
2
  16.7%
30
  24.4%
Male
43
  75.4%
40
  74.1%
10
  83.3%
93
  75.6%
1.Primary Outcome
Title Final Extent Inhibition of Platelet Aggregation (IPA) Induced by 20 µM Adenosine Diphosphate (ADP) at 2 Hours After First Dose
Hide Description IPA(%)=(PAb-PAt)/PAb*100.The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time Frame At 2 hours after first dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
Arm/Group Title Ticagrelor Clopidogrel
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Overall Number of Participants Analyzed 48 49
Median (Inter-Quartile Range)
Unit of Measure: Percentage
93.15
(80.4 to 100.0)
31.05
(10.3 to 56.9)
2.Primary Outcome
Title Slope of Extent IPA Offset Curve 4 to 72 Hours After Last Dose of Study Drug
Hide Description IPA(%)=(PAb-PAt)/PAb*100.The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. The unit for the slope of IPA curve is percent/hour.
Time Frame 4 to 72 Hours after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
Arm/Group Title Ticagrelor Clopidogrel
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Overall Number of Participants Analyzed 54 50
Least Squares Mean (Standard Error)
Unit of Measure: Percentage/Hour
-1.037  (0.076) -0.482  (0.055)
3.Secondary Outcome
Title Final Extent IPA Induced by 20 µM ADP at 0.5 Hours After First Dose
Hide Description IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time Frame 0.5 hours after first dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
Arm/Group Title Ticagrelor Clopidogrel
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Overall Number of Participants Analyzed 49 47
Median (Inter-Quartile Range)
Unit of Measure: Percentage
45.39
(3.0 to 66.4)
4.71
(0.0 to 14.8)
4.Secondary Outcome
Title Final Extent IPA Induced by 20 µM ADP at 1 Hour After First Dose
Hide Description IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time Frame 1 hour after first dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
Arm/Group Title Ticagrelor Clopidogrel
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Overall Number of Participants Analyzed 47 47
Median (Inter-Quartile Range)
Unit of Measure: Percentage
86.71
(72.6 to 99.4)
15.83
(0.0 to 32.5)
5.Secondary Outcome
Title Final Extent IPA Induced by 20 µM ADP at 4 Hours After First Dose
Hide Description IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time Frame 4 hours after first dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
Arm/Group Title Ticagrelor Clopidogrel
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Overall Number of Participants Analyzed 49 48
Median (Inter-Quartile Range)
Unit of Measure: Percentage
98.39
(84.2 to 100.0)
40.87
(16.6 to 69.3)
6.Secondary Outcome
Title Final Extent IPA Induced by 20 µM ADP at 8 Hours After First Dose
Hide Description IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time Frame 8 hours after first dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
Arm/Group Title Ticagrelor Clopidogrel
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Overall Number of Participants Analyzed 53 47
Median (Inter-Quartile Range)
Unit of Measure: Percentage
96.99
(81.1 to 100.0)
46.90
(20.4 to 80.8)
7.Secondary Outcome
Title Final Extent IPA Induced by 20 µM ADP at 24 Hours After First Dose
Hide Description IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time Frame 24 hours after first dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
Arm/Group Title Ticagrelor Clopidogrel
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Overall Number of Participants Analyzed 52 46
Median (Inter-Quartile Range)
Unit of Measure: Percentage
87.29
(62.9 to 98.4)
49.64
(17.7 to 76.9)
8.Secondary Outcome
Title Final Extent IPA Induced by 20 µM ADP at 0 Hour Before Last Dose
Hide Description IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time Frame 0 hour before last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
Arm/Group Title Ticagrelor Clopidogrel
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Overall Number of Participants Analyzed 44 42
Median (Inter-Quartile Range)
Unit of Measure: Percentage
74.53
(56.5 to 98.3)
51.75
(32.8 to 66.4)
9.Secondary Outcome
Title Final Extent IPA Induced by 20 µM ADP at 2 Hours After Last Dose
Hide Description IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time Frame 2 hours after last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
Arm/Group Title Ticagrelor Clopidogrel
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Overall Number of Participants Analyzed 45 43
Median (Inter-Quartile Range)
Unit of Measure: Percentage
91.49
(83.0 to 100.0)
62.96
(35.2 to 78.8)
10.Secondary Outcome
Title Final Extent IPA Induced by 20 µM ADP at 4 Hours After Last Dose
Hide Description IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time Frame 4 hours after last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
Arm/Group Title Ticagrelor Clopidogrel
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Overall Number of Participants Analyzed 47 44
Median (Inter-Quartile Range)
Unit of Measure: Percentage
96.10
(80.4 to 100.0)
61.80
(35.2 to 88.4)
11.Secondary Outcome
Title Final Extent IPA Induced by 20 µM ADP at 8 Hours After Last Dose
Hide Description IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time Frame 8 hours after last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
Arm/Group Title Ticagrelor Clopidogrel
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Overall Number of Participants Analyzed 47 44
Median (Inter-Quartile Range)
Unit of Measure: Percentage
88.31
(77.3 to 100.0)
61.31
(39.0 to 61.31)
12.Secondary Outcome
Title Final Extent IPA Induced by 20 µM ADP at 24 Hours After Last Dose
Hide Description IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time Frame 24 hours after last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
Arm/Group Title Ticagrelor Clopidogrel
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Overall Number of Participants Analyzed 48 45
Median (Inter-Quartile Range)
Unit of Measure: Percentage
55.18
(39.1 to 85.4)
53.91
(35.1 to 73.3)
13.Secondary Outcome
Title Final Extent IPA Induced by 20 µM ADP at 48 Hours After Last Dose
Hide Description IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time Frame 48 hours after last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
Arm/Group Title Ticagrelor Clopidogrel
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Overall Number of Participants Analyzed 49 43
Median (Inter-Quartile Range)
Unit of Measure: Percentage
30.94
(14.3 to 51.5)
45.79
(19.4 to 54.7)
14.Secondary Outcome
Title Final Extent IPA Induced by 20 µM ADP at 72 Hours After Last Dose
Hide Description IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time Frame 72 hours after last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
Arm/Group Title Ticagrelor Clopidogrel
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Overall Number of Participants Analyzed 49 42
Median (Inter-Quartile Range)
Unit of Measure: Percentage
11.76
(0.0 to 34.5)
21.09
(10.2 to 47.6)
15.Secondary Outcome
Title Final Extent IPA Induced by 20 µM ADP at 120 Hours - Day 5 After Last Dose
Hide Description IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time Frame 120 hours - Day 5 after last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
Arm/Group Title Ticagrelor Clopidogrel
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Overall Number of Participants Analyzed 49 41
Median (Inter-Quartile Range)
Unit of Measure: Percentage
0.0
(0.0 to 15.2)
21.15
(0.0 to 34.7)
16.Secondary Outcome
Title Final Extent IPA Induced by 20 µM ADP at 168 Hours - Day 7 After Last Dose
Hide Description IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference of baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time Frame 168 hours - Day 7 after last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
Arm/Group Title Ticagrelor Clopidogrel
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Overall Number of Participants Analyzed 47 41
Median (Inter-Quartile Range)
Unit of Measure: Percentage
0.0
(0.0 to 11.7)
6.32
(0.0 to 22.4)
17.Secondary Outcome
Title Final Extent IPA Induced by 20 µM ADP at 240 Hours - Day 10 After Last Dose
Hide Description IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time Frame 240 hours - Day 10 after last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
Arm/Group Title Ticagrelor Clopidogrel
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Overall Number of Participants Analyzed 48 44
Median (Inter-Quartile Range)
Unit of Measure: Percentage
1.64
(0.0 to 9.9)
0.98
(0.0 to 13.8)
18.Secondary Outcome
Title Cardiopulmonary Parameters at Baseline: Forced Expiratory Volume in 1 Second (FEV1)
Hide Description FEV1 is measured by Spirometry, the unit is Liter.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
Arm/Group Title Ticagrelor Clopidogrel Placebo
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Overall Number of Participants Analyzed 57 54 12
Mean (Standard Deviation)
Unit of Measure: Liter
2.79  (0.725) 2.71  (0.791) 2.94  (0.654)
19.Secondary Outcome
Title Cardiopulmonary Parameters at Post 6-week Treatment: FEV1
Hide Description FEV1 is measured by Spirometry, the unit is Liter.
Time Frame 6-week post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
Arm/Group Title Ticagrelor Clopidogrel Placebo
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Overall Number of Participants Analyzed 53 51 11
Mean (Standard Deviation)
Unit of Measure: Liter
2.77  (0.712) 2.74  (0.751) 2.95  (0.727)
20.Secondary Outcome
Title Cardiopulmonary Parameters at Baseline: Forced Vital Capacity (FVC)
Hide Description FVC is measured by Spirometry, the unit is Liter.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
Arm/Group Title Ticagrelor Clopidogrel Placebo
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Overall Number of Participants Analyzed 57 54 12
Mean (Standard Deviation)
Unit of Measure: Liter
3.72  (0.903) 3.73  (1.082) 4.03  (0.858)
21.Secondary Outcome
Title Cardiopulmonary Parameters at Post 6-week Treatment: FVC
Hide Description FVC is measured by Spirometry, the unit is Liter.
Time Frame 6-week post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
Arm/Group Title Ticagrelor Clopidogrel Placebo
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Overall Number of Participants Analyzed 53 51 11
Mean (Standard Deviation)
Unit of Measure: Liter
3.70  (0.933) 3.78  (1.029) 3.98  (0.890)
22.Secondary Outcome
Title Cardiopulmonary Parameters at Baseline: Ratio of Forced Expiratory Volume in 1 Second Over Forced Vital Capacity (FEV1/FVC Ratio)
Hide Description FEV1/FVC Ratio is measured by Spirometry, the unit is Ratio.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
Arm/Group Title Ticagrelor Clopidogrel Placebo
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Overall Number of Participants Analyzed 57 54 12
Mean (Standard Deviation)
Unit of Measure: Ratio
75.01  (7.049) 73.04  (6.764) 73.13  (7.226)
23.Secondary Outcome
Title Cardiopulmonary Parameters at Post 6-week Treatment: FEV1/FVC Ratio
Hide Description FEV1/FVC Ratio is measured by Spirometry, the unit is Ratio.
Time Frame 6-week post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
Arm/Group Title Ticagrelor Clopidogrel Placebo
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Overall Number of Participants Analyzed 53 51 11
Mean (Standard Deviation)
Unit of Measure: Ratio
74.71  (5.694) 72.84  (6.371) 74.27  (7.836)
24.Secondary Outcome
Title Cardiopulmonary Parameters at Baseline: Mean Forced Expiratory Flow Between 25% and 75% of the FVC (FEF25-75)
Hide Description FEF25-75 is measured by Spirometry, the unit is Liter/Second.
Time Frame Baseline
Hide Outcome Measure Data
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Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
Arm/Group Title Ticagrelor Clopidogrel Placebo
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Overall Number of Participants Analyzed 57 54 12
Mean (Standard Deviation)
Unit of Measure: Liter/second
2.88  (1.251) 2.70  (1.208) 2.50  (1.243)
25.Secondary Outcome
Title Cardiopulmonary Parameters Post 6-week Treatment: FEF25-75
Hide Description FEF25-75 is measured by Spirometry, the unit is Liter/Second.
Time Frame 6-week post treatment
Hide Outcome Measure Data
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Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
Arm/Group Title Ticagrelor Clopidogrel Placebo
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Overall Number of Participants Analyzed 53 51 11
Mean (Standard Deviation)
Unit of Measure: Liter/second
2.77  (1.289) 2.67  (1.156) 2.91  (1.375)
26.Secondary Outcome
Title Cardiopulmonary Parameters at Baseline: Functional Residual Capacity (FRC)
Hide Description FRC is measured by Body Box Plethysmography, the unit is Liter.
Time Frame Baseline
Hide Outcome Measure Data
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Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
Arm/Group Title Ticagrelor Clopidogrel Placebo
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Overall Number of Participants Analyzed 55 53 12
Mean (Standard Deviation)
Unit of Measure: Liter
2.79  (0.827) 2.89  (0.876) 2.91  (0.679)
27.Secondary Outcome
Title Cardiopulmonary Parameters Post 6-week Treatment: FRC
Hide Description FRC is measured by Body Box Plethysmography, the unit is Liter.
Time Frame 6-week post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
Arm/Group Title Ticagrelor Clopidogrel Placebo
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Overall Number of Participants Analyzed 53 51 11
Mean (Standard Deviation)
Unit of Measure: Liter
2.73  (0.723) 2.79  (0.857) 2.75  (1.000)
28.Secondary Outcome
Title Cardiopulmonary Parameters at Baseline: Total Lung Capacity (TLC)
Hide Description TLC is measured by Body Box Plethysmography, the unit is Liter.
Time Frame Baseline
Hide Outcome Measure Data
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Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
Arm/Group Title Ticagrelor Clopidogrel Placebo
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Overall Number of Participants Analyzed 55 53 12
Mean (Standard Deviation)
Unit of Measure: Liter
5.78  (1.299) 5.83  (1.401) 6.10  (1.037)
29.Secondary Outcome
Title Cardiopulmonary Parameters Post 6-week Treatment: TLC
Hide Description TLC is measured by Body Box Plethysmography, the unit is Liter.
Time Frame 6-week post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
Arm/Group Title Ticagrelor Clopidogrel Placebo
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Overall Number of Participants Analyzed 53 51 11
Mean (Standard Deviation)
Unit of Measure: Liter
5.70  (1.182) 5.85  (1.396) 5.96  (1.422)
30.Secondary Outcome
Title Cardiopulmonary Parameters at Baseline: Residual Volume (RV)
Hide Description RV is measured by Body Box Plethysmography, the unit is Liter.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
Arm/Group Title Ticagrelor Clopidogrel Placebo
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Overall Number of Participants Analyzed 55 53 12
Mean (Standard Deviation)
Unit of Measure: Liter
1.94  (0.780) 2.01  (0.643) 1.91  (0.363)
31.Secondary Outcome
Title Cardiopulmonary Parameters Post 6-week Treatment: RV
Hide Description RV is measured by Body Box Plethysmography, the unit is Liter.
Time Frame 6-week post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
Arm/Group Title Ticagrelor Clopidogrel Placebo
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Overall Number of Participants Analyzed 53 51 11
Mean (Standard Deviation)
Unit of Measure: Liter
1.88  (0.621) 1.97  (0.559) 1.90  (0.751)
32.Secondary Outcome
Title Cardiopulmonary Parameters at Baseline: Minute Ventilation (VE)
Hide Description VE is measured by Spirometry and Body Box Plethysmography, the unit is Liter/Minute
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
Arm/Group Title Ticagrelor Clopidogrel Placebo
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Overall Number of Participants Analyzed 55 50 12
Mean (Standard Deviation)
Unit of Measure: Liter/minute
12.92  (3.950) 12.17  (3.552) 12.06  (4.054)
33.Secondary Outcome
Title Cardiopulmonary Parameters Post 6-week Treatment: VE
Hide Description VE is measured by Spirometry and Body Box Plethysmography, the unit is Liter/Minute
Time Frame 6-week post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
Arm/Group Title Ticagrelor Clopidogrel Placebo
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Overall Number of Participants Analyzed 53 50 11
Mean (Standard Deviation)
Unit of Measure: Liter/minute
13.69  (3.582) 13.14  (5.515) 11.45  (3.540)
34.Secondary Outcome
Title Cardiopulmonary Parameters at Baseline: Respiratory Rate (RR)
Hide Description RR is measured by Spirometry and Body Box Plethysmography, the unit is Breaths/Minute.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
Arm/Group Title Ticagrelor Clopidogrel Placebo
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Overall Number of Participants Analyzed 57 54 12
Mean (Standard Deviation)
Unit of Measure: Breaths/minute
14.79  (2.433) 14.15  (2.743) 15.5  (1.977)
35.Secondary Outcome
Title Cardiopulmonary Parameters Post 6-week Treatment: RR
Hide Description RR is measured by Spirometry and Body Box Plethysmography, the unit is Breaths/Minute.
Time Frame 6-week post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
Arm/Group Title Ticagrelor Clopidogrel Placebo
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Overall Number of Participants Analyzed 53 52 11
Mean (Standard Deviation)
Unit of Measure: Breaths/minute
15.21  (2.817) 15.10  (2.303) 14.91  (0.944)
36.Secondary Outcome
Title Cardiopulmonary Parameters at Baseline: Tidal Volume (VT)
Hide Description VT is measured by Body Box Plethysmography, the unit is Liter/Minute.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
Arm/Group Title Ticagrelor Clopidogrel Placebo
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Overall Number of Participants Analyzed 55 50 12
Mean (Standard Deviation)
Unit of Measure: Liters/minute
0.96  (0.326) 0.89  (0.322) 0.89  (0.273)
37.Secondary Outcome
Title Cardiopulmonary Parameters Post 6-week Treatment: VT
Hide Description VT is measured by Body Box Plethysmography, the unit is Liter/Minute.
Time Frame 6-week post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
Arm/Group Title Ticagrelor Clopidogrel Placebo
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Overall Number of Participants Analyzed 53 50 11
Mean (Standard Deviation)
Unit of Measure: Liters/minute
0.92  (0.264) 0.93  (0.393) 0.83  (0.329)
38.Secondary Outcome
Title Cardiopulmonary Parameters at Baseline: Single Breath Diffusing Capacity for the Lungs Using Carbon Monoxide (DLCOSB)
Hide Description DLCOSB is measured by Body Box Plethysmography, the unit is Percent.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
Arm/Group Title Ticagrelor Clopidogrel Placebo
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Overall Number of Participants Analyzed 57 54 12
Mean (Standard Deviation)
Unit of Measure: Percent
17.00  (8.673) 17.29  (10.891) 15.83  (6.013)
39.Secondary Outcome
Title Cardiopulmonary Parameters Post 6-week Treatment: DLCOSB
Hide Description DLCOSB is measured by Body Box Plethysmography, the unit is Percent.
Time Frame 6-week post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
Arm/Group Title Ticagrelor Clopidogrel Placebo
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Overall Number of Participants Analyzed 53 51 11
Mean (Standard Deviation)
Unit of Measure: Percent
16.38  (8.090) 16.53  (8.286) 16.09  (7.190)
40.Secondary Outcome
Title Cardiopulmonary Parameters at Baseline: Ejection Fraction (EF)
Hide Description EF is measured by Echocardiogram, the unit is Percent. The ejection fraction is defined by: (LV diastolic volume - LV systolic volume)/LV diastolic volume. The unit % is the percentage change of left ventricular diastolic versus systolic volume relative to the diastolic volume. LV is the left ventricle.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
Arm/Group Title Ticagrelor Clopidogrel Placebo
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Overall Number of Participants Analyzed 57 54 12
Mean (Standard Deviation)
Unit of Measure: Percent
57.96  (9.302) 61.91  (7.624) 59.92  (10.013)
41.Secondary Outcome
Title Cardiopulmonary Parameters Post 6-week Treatment: EF
Hide Description EF is measured by Echocardiogram, the unit is Percent. The ejection fraction is defined by: (LV diastolic volume - LV systolic volume)/LV diastolic volume. The unit % is the percentage change of left ventricular diastolic versus systolic volume relative to the diastolic volume. LV is the left ventricle.
Time Frame 6-week post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
Arm/Group Title Ticagrelor Clopidogrel Placebo
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Overall Number of Participants Analyzed 53 52 11
Mean (Standard Deviation)
Unit of Measure: Percent
60.70  (8.430) 62.38  (7.096) 60.73  (9.665)
42.Secondary Outcome
Title Cardiopulmonary Parameters at Baseline: N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
Hide Description NT-proBNP is measured by clinical lab, the unit is pg/mL.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
Arm/Group Title Ticagrelor Clopidogrel Placebo
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Overall Number of Participants Analyzed 52 53 12
Mean (Standard Deviation)
Unit of Measure: pg/ml
163.34  (184.298) 185.98  (227.141) 145.41  (144.522)
43.Secondary Outcome
Title Cardiopulmonary Parameters Post 6-week Treatment: NT-proBNP
Hide Description NT-proBNP is measured by clinical lab, the unit is pg/mL.
Time Frame 6-week post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
Arm/Group Title Ticagrelor Clopidogrel Placebo
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Overall Number of Participants Analyzed 43 48 11
Mean (Standard Deviation)
Unit of Measure: pg/ml
139.88  (170.347) 214.43  (313.429) 140.68  (145.003)
44.Secondary Outcome
Title Cardiopulmonary Parameters at Baseline: Blood Oxygen Saturation Measured by Pulse Oximetry (SpO2)
Hide Description SpO2 is measured by pulse oximetry, the unit is Percent. The unit % is the percentage of oxygen attached hemoglobin relative to the total hemoglobin.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
Arm/Group Title Ticagrelor Clopidogrel Placebo
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Overall Number of Participants Analyzed 56 54 12
Mean (Standard Deviation)
Unit of Measure: Percent
96.59  (1.570) 96.78  (1.949) 97.58  (1.240)
45.Secondary Outcome
Title Cardiopulmonary Parameters Post 6-week Treatment: SpO2
Hide Description SpO2 is measured by pulse oximetry, the unit is Percent. The unit % is the percentage of oxygen attached hemoglobin relative to the total hemoglobin.
Time Frame 6-week post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
Arm/Group Title Ticagrelor Clopidogrel Placebo
Hide Arm/Group Description:
Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
Overall Number of Participants Analyzed 52 51 9
Mean (Standard Deviation)
Unit of Measure: Percentage
97.73  (1.239) 97.35  (1.262) 98.56  (1.014)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ticagrelor Clopidogrel Placebo
Hide Arm/Group Description Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
All-Cause Mortality
Ticagrelor Clopidogrel Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ticagrelor Clopidogrel Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/57 (0.00%)   0/54 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ticagrelor Clopidogrel Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   36/57 (63.16%)   22/54 (40.74%)   7/12 (58.33%) 
Cardiac disorders       
Angina Pectoris  1  3/57 (5.26%)  1/54 (1.85%)  0/12 (0.00%) 
Palpitations  1  3/57 (5.26%)  0/54 (0.00%)  0/12 (0.00%) 
Eye disorders       
Visual Impairment  1  0/57 (0.00%)  0/54 (0.00%)  1/12 (8.33%) 
Gastrointestinal disorders       
Dyspepsia  1  2/57 (3.51%)  0/54 (0.00%)  1/12 (8.33%) 
Abdominal Wall Haematoma  1  0/57 (0.00%)  0/54 (0.00%)  1/12 (8.33%) 
General disorders       
Vessel Puncture Site Haematoma  1  3/57 (5.26%)  5/54 (9.26%)  1/12 (8.33%) 
Fatigue  1  4/57 (7.02%)  2/54 (3.70%)  1/12 (8.33%) 
Oedema Peripheral  1  4/57 (7.02%)  2/54 (3.70%)  0/12 (0.00%) 
Chest Discomfort  1  1/57 (1.75%)  0/54 (0.00%)  1/12 (8.33%) 
Infections and infestations       
Nasopharyngitis  1  4/57 (7.02%)  4/54 (7.41%)  0/12 (0.00%) 
Cellulitis  1  0/57 (0.00%)  0/54 (0.00%)  1/12 (8.33%) 
Injury, poisoning and procedural complications       
Contusion  1  6/57 (10.53%)  3/54 (5.56%)  0/12 (0.00%) 
Electrocardiogram Poor R-Wave Progression  1  0/57 (0.00%)  0/54 (0.00%)  1/12 (8.33%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  4/57 (7.02%)  1/54 (1.85%)  0/12 (0.00%) 
Neck Pain  1  0/57 (0.00%)  0/54 (0.00%)  1/12 (8.33%) 
Pain In Extremity  1  0/57 (0.00%)  1/54 (1.85%)  1/12 (8.33%) 
Nervous system disorders       
Dizziness  1  1/57 (1.75%)  2/54 (3.70%)  1/12 (8.33%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  20/57 (35.09%)  6/54 (11.11%)  0/12 (0.00%) 
Dyspnoea Exertional  1  3/57 (5.26%)  0/54 (0.00%)  1/12 (8.33%) 
Epistaxis  1  3/57 (5.26%)  0/54 (0.00%)  0/12 (0.00%) 
Skin and subcutaneous tissue disorders       
Increased Tendency To Bruise  1  9/57 (15.79%)  2/54 (3.70%)  0/12 (0.00%) 
Dermatitis Allergic  1  0/57 (0.00%)  0/54 (0.00%)  1/12 (8.33%) 
Vascular disorders       
Hypertension  1  3/57 (5.26%)  1/54 (1.85%)  0/12 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
An Investigator agrees to provide a copy of the publication to AZ for review at least 60 days in advance of submission for publication. Investigators in multicenter (MC) studies agree to postpone MC publications until the earlier of the date of the first AZ-authorized MC publication or a period up to 18 months from study completion at all sites.
Results Point of Contact
Name/Title: Gerard Lynch
Organization: AstraZeneca
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00528411     History of Changes
Other Study ID Numbers: D5130C00048
First Submitted: September 10, 2007
First Posted: September 12, 2007
Results First Submitted: January 27, 2011
Results First Posted: January 11, 2012
Last Update Posted: January 13, 2012