Ticagrelor Versus Clopidogrel in Type 2 Diabetic Patients
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01823510 |
|
Recruitment Status :
Completed
First Posted : April 4, 2013
Results First Posted : September 1, 2017
Last Update Posted : December 8, 2017
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| 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 |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Arm | Intervention/treatment |
|---|---|
|
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).
Other Names:
|
|
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).
Other Names:
|
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosed with type-2 diabetes being treated with oral or parenteral hypoglycemic therapy or both.
- Have not had thienopyridine therapy for at least 30 days before the study.
- Are of legal age (at least 18 years of age but less than 75 years of age) and competent mental condition to provide written informed consent.
- For women of child-bearing potential only test negative for pregnancy at the time of enrollment.
Exclusion Criteria:
- Have a defined need for thienopyridine therapy.
- Subjects within ≤30 days of coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI).
- Known glycosylated hemoglobin (HbA1c) ≥10 mg/dL within last 3 months prior to study entry.
- Have received fibrinolytic therapy <48 hours prior to randomization.
- Have active internal bleeding or history of bleeding diathesis.
- Have clinical findings that are, in the judgment of the investigator, associated with an increased risk of bleeding.
- Have history of ischemic or hemorrhagic stroke, transient ischemic attack (TIA) or intracranial neoplasm, arteriovenous malformation, or aneurysm.
- Have an International Normalized Ratio (INR) known to be >1.5 within 1 week of study entry.
- Have a known platelet count of <100,000/mm3 within 1 week of study entry.
- Have known anemia (hemoglobin [Hgb] <10 gm/dL) within 1 week of study entry.
- Are receiving or will receive oral anticoagulation or other antiplatelet therapy (other than ASA) that cannot be safely discontinued for the duration of the trial.
- Are receiving daily treatment with non-steroidal anti-inflammatory drugs (NSAIDS) that cannot be discontinued.
- Have a concomitant medical illness that in the opinion of the investigator may interfere with or prevent completion in this study.
- Have known severe hepatic dysfunction (e.g., cirrhosis or portal hypertension).
- Have a history of intolerance or allergy to ASA or approved thienopyridines (ticlopidine or clopidogrel).
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Juan J Badimon, Professor, Icahn School of Medicine at Mount Sinai |
| ClinicalTrials.gov Identifier: | NCT01823510 History of Changes |
| Other Study ID Numbers: |
GCO 13-0208 |
| First Posted: | April 4, 2013 Key Record Dates |
| Results First Posted: | September 1, 2017 |
| Last Update Posted: | December 8, 2017 |
| Last Verified: | December 2017 |
|
Antiplatelet Ticagrelor Clopidogrel |
Thrombosis Diabetes Coronary Artery Disease |
|
Aspirin Clopidogrel Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Ticagrelor Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents |