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Trial record 56 of 401 for:    ASPIRIN AND clopidogrel AND Purinergic Antagonists

Ticagrelor Versus Clopidogrel in Type 2 Diabetic Patients

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ClinicalTrials.gov Identifier: NCT01823510
Recruitment Status : Completed
First Posted : April 4, 2013
Results First Posted : September 1, 2017
Last Update Posted : December 8, 2017
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: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Type-2 Diabetes Mellitus
Coronary Artery Disease
Interventions Drug: Ticagrelor + Aspirin
Drug: Clopidogrel + Aspirin
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tica-Clop Clop-Tica
Hide Arm/Group Description Participants received Ticagrelor plus ASA (loading-dose plus daily-dose for 5-7 days), followed by Washout (14 days), and then Clopidogrel plus ASA (loading-dose plus daily-dose for 5-7 days). Participants received Clopidogrel plus ASA (loading-dose plus daily-dose for 5-7 days), followed by Washout (14 days), and then Ticagrelor plus ASA (loading-dose plus daily-dose for 5-7 days).
Period Title: Days 1-7
Started 10 10
Completed 10 10
Not Completed 0 0
Period Title: Days 8-21
Started 10 10
Completed 10 10
Not Completed 0 0
Period Title: Days 22-28
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title Type 2 Diabetic Patients
Hide Arm/Group Description All participants receive both Ticagrelor and Clopidogrel (each with aspirin) in a cross-over design. Treatment sequence (Tica-Clop OR Clop-Tica) was randomly assigned and with a 2-week washout period in between (i.e., "Tica/Clop (5-7 days)", "Washout (14 days)", and "Clop/Tica (5-7 days)").
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
57.2  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
8
  40.0%
Male
12
  60.0%
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 20 participants
30.9  (4.5)
Diabetes, type-2  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
20
 100.0%
Hypertension  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
17
  85.0%
Hypercholesterolemia  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
19
  95.0%
Smoking  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
3
  15.0%
1.Primary Outcome
Title Thrombus Formation
Hide Description Thrombus formation in Badimon Perfusion Chamber high-shear) (ex vivo model of thrombosis).
Time Frame up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ticagrelor + Aspirin Clopidogrel + Aspirin
Hide Arm/Group Description:
Single loading doses of Ticagrelor (180 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (ticagrelor 90 mg twice daily + ASA 81 mg once daily).
Single loading doses of Clopidogrel (600 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (clopidogrel 75 mg + ASA 81 mg once daily).
Overall Number of Participants Analyzed 20 20
Mean (Standard Error)
Unit of Measure: percentage of baseline size
2 hour post loading dose 66.9  (8.0) 84.4  (6.4)
6 hours post loading dose 59.9  (8.0) 79.8  (6.4)
5-7 days of maintenance dose 68.9  (8.3) 82.6  (6.5)
2.Secondary Outcome
Title Platelet Reactivity
Hide Description Platelet reactivity by Multiplate Analyzer
Time Frame up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ticagrelor + Aspirin Clopidogrel + Aspirin
Hide Arm/Group Description:
Single loading doses of Ticagrelor (180 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (ticagrelor 90 mg twice daily + ASA 81 mg once daily).
Single loading doses of Clopidogrel (600 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (clopidogrel 75 mg + ASA 81 mg once daily).
Overall Number of Participants Analyzed 20 20
Mean (Standard Error)
Unit of Measure: percentage of baseline Unit
2 hour post-loading dose 20.5  (7.4) 54.5  (14.4)
6 hour post-loading dose 20.6  (7.5) 43.6  (14.6)
5-7 days of maintenance dosing 24.2  (7.7) 45.5  (14.4)
3.Secondary Outcome
Title P2Y12 Reaction Unit (PRU)
Hide Description Platelet reactivity by measuring P2Y12 Reaction Unit using Accumetrics VerifyNow
Time Frame up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ticagrelor + Aspirin Clopidogrel + Aspirin
Hide Arm/Group Description:
Single loading doses of Ticagrelor (180 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (ticagrelor 90 mg twice daily + ASA 81 mg once daily).
Single loading doses of Clopidogrel (600 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (clopidogrel 75 mg + ASA 81 mg once daily).
Overall Number of Participants Analyzed 20 20
Mean (Standard Error)
Unit of Measure: percentage of baseline PRU
2 hour post-loading dose 14.8  (7.2) 77.8  (11.8)
6 hour post-loading dose 8.2  (7.5) 66.8  (11.9)
5-7 days of maintenance dosing 14.5  (7.5) 62.7  (11.8)
4.Secondary Outcome
Title Platelet Reactivity Index (PRI)
Hide Description Platelet reactivity index by Vasodilator-Stimulated Phosphoprotein phosphorylation (VASP) assay.
Time Frame up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ticagrelor + Aspirin Clopidogrel + Aspirin
Hide Arm/Group Description:
Single loading doses of Ticagrelor (180 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (ticagrelor 90 mg twice daily + ASA 81 mg once daily).
Single loading doses of Clopidogrel (600 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (clopidogrel 75 mg + ASA 81 mg once daily).
Overall Number of Participants Analyzed 20 20
Mean (Standard Error)
Unit of Measure: percentage of baseline PRI
2 hour post-loading dose 21.8  (2.5) 85.8  (3.3)
6 hour post-loading dose 17.8  (2.5) 82.5  (3.4)
5-7 days of maintenance dosing 17.2  (2.5) 68.4  (3.4)
Time Frame [Not Specified]
Adverse Event Reporting Description there were no adverse events.
 
Arm/Group Title Ticagrelor + Aspirin Clopidrogel + Aspirin
Hide Arm/Group Description Single loading doses of Ticagrelor (180 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (ticagrelor 90 mg twice daily + ASA 81 mg once daily). Single loading doses of Clopidogrel (600 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (clopidogrel 75 mg + ASA 81 mg once daily).
All-Cause Mortality
Ticagrelor + Aspirin Clopidrogel + Aspirin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Ticagrelor + Aspirin Clopidrogel + Aspirin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (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 + Aspirin Clopidrogel + Aspirin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Juan 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: NCT01823510     History of Changes
Other Study ID Numbers: GCO 13-0208
First Submitted: March 29, 2013
First Posted: April 4, 2013
Results First Submitted: June 19, 2017
Results First Posted: September 1, 2017
Last Update Posted: December 8, 2017