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Trial record 91 of 602 for:    ASPIRIN AND clopidogrel

Antithrombotic Effects of Ticagrelor Versus Clopidogrel

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ClinicalTrials.gov Identifier: NCT01642238
Recruitment Status : Completed
First Posted : July 17, 2012
Results First Posted : July 11, 2016
Last Update Posted : July 11, 2016
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Juan J Badimon, Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Coronary Syndrome
Interventions Drug: Ticagrelor + ASA + Bivalirudin
Drug: Clopidogrel + ASA + Bivalirudin
Enrollment 15
Recruitment Details 15 healthy volunteers recruited between July 2012 and March 2013
Pre-assignment Details  
Arm/Group Title Ticagrelor, Then Clopidogrel Clopidogrel, Then Ticagrelor
Hide Arm/Group Description Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) with a 1-2 week washout period in between. Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) with a 1-2 week washout period in between.
Period Title: First Intervention (1 Day)
Started 7 8
Completed 7 8
Not Completed 0 0
Period Title: Washout (1-2 Weeks)
Started 7 8
Completed 7 8
Not Completed 0 0
Period Title: Second Intervention (1 Day)
Started 7 8
Completed 7 8
Not Completed 0 0
Arm/Group Title Antithrombotic Effects
Hide Arm/Group Description Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) using a randomized, two-treatment, two-period, cross-over design in healthy volunteers.
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants
31.2
(26.8 to 35.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
6
  40.0%
Male
9
  60.0%
Body mass index  
Mean (Full Range)
Unit of measure:  Kg/m^2
Number Analyzed 15 participants
27.0
(24.9 to 29.1)
1.Primary Outcome
Title Platelet-thrombus Formation in an ex Vivo Model of Thrombosis
Hide Description Change in thrombus size at 1 hour as compared to Pre-treatment baseline, where a positive change represents a decrease in thrombus size.
Time Frame Pre-treatment baseline and 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ticagrelor + ASA + Bivalirudin Clopidogrel + ASA + Bivalirudin
Hide Arm/Group Description:

Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Overall Number of Participants Analyzed 15 15
Mean (95% Confidence Interval)
Unit of Measure: percent change
56.3
(43.5 to 69.0)
35.2
(23.9 to 46.5)
2.Primary Outcome
Title Platelet-thrombus Formation in an ex Vivo Model of Thrombosis
Hide Description Change in thrombus size at 24 hours as compared to Pre-treatment baseline, where a positive change represents a decrease in thrombus size.
Time Frame Pre-treatment baseline and 24 hrs post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ticagrelor + ASA + Bivalirudin Clopidogrel + ASA + Bivalirudin
Hide Arm/Group Description:

Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Overall Number of Participants Analyzed 15 15
Mean (95% Confidence Interval)
Unit of Measure: percent change
34.1
(24.3 to 43.9)
18.5
(4.2 to 32.7)
3.Secondary Outcome
Title Platelet Reactivity
Hide Description Platelet reactivity measured by VerifyNowP2Y12 assay measuring percent inhibition
Time Frame Pre-treatment baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ticagrelor + ASA + Bivalirudin Clopidogrel + ASA + Bivalirudin
Hide Arm/Group Description:

Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Overall Number of Participants Analyzed 15 15
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent inhibition
2.9
(0.5 to 5.3)
3.7
(0.9 to 6.6)
4.Secondary Outcome
Title Platelet Reactivity
Hide Description Platelet reactivity measured by VerifyNowP2Y12 assay measuring percent inhibition
Time Frame 1 hr post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ticagrelor + ASA + Bivalirudin Clopidogrel + ASA + Bivalirudin
Hide Arm/Group Description:

Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Overall Number of Participants Analyzed 15 15
Mean (95% Confidence Interval)
Unit of Measure: percent inhibition
69.4
(52.9 to 85.9)
20.1
(14.5 to 25.8)
5.Secondary Outcome
Title Platelet Reactivity
Hide Description Platelet reactivity measured by VerifyNowP2Y12 assay measuring percent inhibition
Time Frame 24-hours post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ticagrelor + ASA + Bivalirudin Clopidogrel + ASA + Bivalirudin
Hide Arm/Group Description:

Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Overall Number of Participants Analyzed 15 15
Mean (95% Confidence Interval)
Unit of Measure: percent inhibition
67.4
(54.7 to 80.1)
53.4
(38.7 to 68.1)
6.Secondary Outcome
Title Blood Thrombogenicity
Hide Description Coagulation times, assessed using the ROTEM thromboelastometry
Time Frame Pre-treatment baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ticagrelor + ASA + Bivalirudin Clopidogrel + ASA + Bivalirudin
Hide Arm/Group Description:

Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Overall Number of Participants Analyzed 15 15
Mean (95% Confidence Interval)
Unit of Measure: seconds
53.1
(48.8 to 57.5)
51.1
(45.0 to 57.2)
7.Secondary Outcome
Title Blood Thrombogenicity
Hide Description Coagulation times, assessed using the ROTEM thromboelastometry
Time Frame 1 hr post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ticagrelor + ASA + Bivalirudin Clopidogrel + ASA + Bivalirudin
Hide Arm/Group Description:

Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Overall Number of Participants Analyzed 15 15
Mean (95% Confidence Interval)
Unit of Measure: seconds
163.1
(145.8 to 180.5)
174.0
(155.5 to 192.5)
8.Secondary Outcome
Title Blood Thrombogenicity
Hide Description Coagulation times, assessed using the ROTEM thromboelastometry
Time Frame 24-hours post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ticagrelor + ASA + Bivalirudin Clopidogrel + ASA + Bivalirudin
Hide Arm/Group Description:

Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.

Overall Number of Participants Analyzed 15 15
Mean (95% Confidence Interval)
Unit of Measure: seconds
56.1
(50.8 to 61.4)
54.3
(49.6 to 59.1)
Time Frame there were no adverse events
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ticagrelor, Then Clopidogrel Clopidogrel, Then Ticagrelor
Hide Arm/Group Description Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) with a 1-2 week wash out period in between. Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) with a 1-2 week wash out period in between.
All-Cause Mortality
Ticagrelor, Then Clopidogrel Clopidogrel, Then Ticagrelor
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ticagrelor, Then Clopidogrel Clopidogrel, Then Ticagrelor
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ticagrelor, Then Clopidogrel Clopidogrel, Then Ticagrelor
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Juan J. Badimon
Organization: Icahn School of Medicine at Mount Sinai
Phone: (212) 241-8484
Responsible Party: Juan J Badimon, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01642238     History of Changes
Other Study ID Numbers: GCO 12-0732
ISSBRIL0067
First Submitted: July 13, 2012
First Posted: July 17, 2012
Results First Submitted: August 14, 2014
Results First Posted: July 11, 2016
Last Update Posted: July 11, 2016