Ticagrelor Versus Clopidogrel in Type 2 Diabetic Patients
Condition: Type-2 Diabetes Mellitus; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Diabetes Mellitus, Type 2
Intervention: Ticagrelor + Aspirin; Clopidogrel + Aspirin
Intervention 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).
Intervention MeSH terms: Aspirin; Clopidogrel; Ticagrelor
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Antiplatelet; Ticagrelor; Clopidogrel; Thrombosis; Diabetes; Coronary Artery Disease

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.
    

Eligibility 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).