Ticagrelor Versus Clopidogrel in Type 2 Diabetic Patients

• Status: Completed
• Trial end date: 2016-05-10
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Juan J Badimon
• Collaborator: AstraZeneca
• Treatments: Aspirin; Clopidogrel; Ticagrelor; Ticlopidine

Criteria

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).