Ticagrelor Versus Clopidogrel in Type 2 Diabetic Patients

Completed · Phase 4

Conditions studied: Type-2 Diabetes Mellitus, Coronary Artery Disease

In brief

The purpose of this study is to determine whether treatment with ticagrelor + aspirin is more effective than treatment with clopidogrel + aspirin in patients with type-2 diabetes. Both treatments will be given (separately) to all subjects as a one-time loading dose (i.e. higher than a normal daily dose), followed by daily dose for the next 5 to 7 days. Effectiveness of treatment will be measured with specialized blood tests before the loading dose, at two time-points after the loading dose, and once after the last daily dose.

Key facts

Study ID

NCT01823510

Run by

Juan J Badimon

People needed

20

Starts

2013-07-01

Expected to finish

2016-05-10

Last updated by the study team

2017-12-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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