Third Optimizing Anti-Platelet Therapy in Diabetes MellitUS (OPTIMUS-3)
Condition: Diabetes Mellitus; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Diabetes Mellitus
Intervention: prasugrel; Clopidogrel
Intervention description: Oral prasugrel 60-mg loading dose, followed by 6-9 days of oral prasugrel 10-mg/day tablet maintenance dose.; Oral clopidogrel 600-mg loading dose, followed by 6-9 days of oral clopidogrel 150-mg/day tablet maintenance dose.
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      This trial is designed as a phase 2 randomized, double-blind double dummy, active comparator
      controlled, two-period two-arm crossover study to enroll 40 patients across multiple centers.
      The study will compare platelet function following a prasugrel loading dose and 1 week of
      prasugrel maintenance therapy with high-dose clopidogrel loading dose and 1 week of high-dose
      clopidogrel maintenance therapy in patients with drug treated type 2 diabetes mellitus who
      have coronary artery disease. Various assays of platelet function will be used in this study.
      Platelet function will be studied using the following assays: Accumetrics VerifyNowTM P2Y12,
      Light Transmittance Aggregometry (LTA), Vasodilator-associated stimulated phosphoprotein
      (VASP), and Thromboelastography (TEG)-platelet mapping.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 Diabetes Mellitus and on oral or parenteral hypoglycemic therapy for at least 1
             month.

          -  History of Coronary Artery Disease with or without other types of vascular disease
             (such as peripheral vascular disease).

          -  Taking Aspirin 75-325 mg/day for at least 1 week prior to randomization.

          -  Between the ages of 18-74 years old.

          -  If a woman of child bearing age, must not be pregnant and must agree to use reliable
             method of birth control during the duration of the study.

        Exclusion Criteria:

          -  Thienopyridine therapy within 30 days or have a defined need for thienopyridine
             treatment.

          -  Coronary Artery Bypass Graft (CABG) or Percutaneous Coronary Intervention (PCI) with
             no stent placed within 30 days.

          -  Planned coronary revascularization

          -  Hemoglobin A1c (HbA1c) > or equal to 10 mg/dL within the last 3 months.

          -  Received fibrolytic therapy <24 hours prior to randomization.

          -  Received non-fibrin-specific fibrinolytic therapy <48 hours prior to randomization.

          -  At risk of bleeding.

          -  History of ischemic stroke, transient ischemic attack (TIA), intercranial neoplasm,
             arteriovenous malformation, or aneurysm.

          -  Body weight <60 kilograms (kg).

          -  International Normalized Ratio (INR) >1.5, platelet count <100,000/mm3, or anemia
             (hemoglobin <10 gm/dL) within 1 week of study entry.

          -  Are receiving or will receive oral anticoagulation or antiplatelet treatment therapy.

          -  Are being treated with daily non-steroidal anti-inflammatory drugs (NSAIDS).

          -  Are pregnant, breast-feeding or plan to become pregnant.