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
|Condition or disease||Intervention/treatment||Phase|
|Type-2 Diabetes Mellitus Coronary Artery Disease||Drug: Ticagrelor + Aspirin Drug: Clopidogrel + Aspirin||Phase 4|
The rising prevalence of diabetes mellitus and its associated cardiovascular complications present a major burden to healthcare providers worldwide. Cardiovascular mortality is much higher among subjects with Type 2 Diabetes Mellitus (T2DM). Increased platelet reactivity is considered a potential link between the two diseases. Thus, given the higher blood thrombogenicity of T2DM with CAD, the availability of more potent antiplatelet drugs should be associated with improvements in the prevention of cardiovascular events in the diabetic populations. Ticagrelor has been shown to possess a faster onset of action and more potency than clopidogrel. Furthermore, the PLATO has shown that these characteristics results in a significant reduction in Cardiovascular events and even death as compared with Clopidogrel.
We plan to compare the antithrombotic activity of ticagrelor versus clopidogrel in T2DM patients using a cross-over study design. Each participant will be randomly assigned to receive ticagrelor/clopidogrel + aspirin as a loading dose followed by 5-7 days of daily maintenance dosing. After a washout period of 1-2 weeks, each participant will receive the second treatment (clopidogrel/ticagrelor + aspirin) again as a loading dose followed by 5-7 days of daily dosing. Platelet function will be tested at pre-treatment baseline, two post-dose time-points on the day of loading dose, and one time-point after the last maintenance dose on day 5-7. Platelet testing will be carried out using the following methodologies:
- Badimon Perfusion Chamber: an ex-vivo model of thrombosis that has been extensively utilized for evaluation of antithrombotic or prothrombotic effects under various pathological states. The model involves native blood perfusing over a thrombogenic substrate, triggering thrombus formation that can be measured by planimetry.
- Platelet Aggregation - Multiplate Analyzer.
- Platelet Aggregation - VerifyNow P2Y12 assay.
- Vasodilator-Stimulated Phosphoprotein (VASP).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Comparative Study of the Antithrombotic Effects of Ticagrelor and Clopidogrel in Type 2 Diabetic Patients|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||May 10, 2016|
|Actual Study Completion Date :||May 10, 2016|
Experimental: Ticagrelor + Aspirin
Loading-dose plus daily-dosing for 5-7 days.
Drug: Ticagrelor + Aspirin
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).
Active Comparator: Clopidogrel + Aspirin
Loading-dose plus daily-dosing for 5-7 days.
Drug: Clopidogrel + Aspirin
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).
- Thrombus Formation [ Time Frame: up to 7 days ]Thrombus formation in Badimon Perfusion Chamber high-shear) (ex vivo model of thrombosis).
- Platelet Reactivity [ Time Frame: up to 7 days ]Platelet reactivity by Multiplate Analyzer
- P2Y12 Reaction Unit (PRU) [ Time Frame: up to 7 days ]Platelet reactivity by measuring P2Y12 Reaction Unit using Accumetrics VerifyNow
- Platelet Reactivity Index (PRI) [ Time Frame: up to 7 days ]Platelet reactivity index by Vasodilator-Stimulated Phosphoprotein phosphorylation (VASP) assay.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01823510
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Juan J Badimon, PhD||Icahn School of Medicine at Mount Sinai|