Comparison of Prasugrel and Clopidogrel in Low Body Weight Versus Higher Body Weight With Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Body Weight
Intervention: prasugrel; clopidogrel
Intervention description: Administered orally, daily for 12 days; Administered orally, daily for 12 days
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: Platelet function

Summary:

      The 5-milligram (mg) dose of prasugrel in low body weight (LBW) patients with coronary artery
      disease produces a pharmacodynamic response within the same therapeutic range as 10-mg dose
      in higher body weight (HBW) patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with a history of stable coronary artery disease who are not currently
             indicated for treatment with a thienopyridine (that is, prasugrel, clopidogrel, or
             ticlopidine)

          -  Provision of written informed consent

          -  For women of child-bearing potential only (that is, women who are not surgically or
             chemically sterilised and who are between menarche and 1 year post menopause), test
             negative for pregnancy (based on a urine or serum pregnancy test to be performed
             before randomisation) and agree to use a reliable method of birth control during the
             study

        Exclusion Criteria:

          -  Unstable coronary artery disease

          -  Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Graft Surgery
             (CABG) within the previous 90 days

          -  History of refractory ventricular arrhythmias within the last 6 months; an implanted
             defibrillator device; congestive heart failure within 6 months prior to screening;
             major surgery, or severe trauma, fracture or organ biopsy within 3 months prior to
             enrollment

          -  Any planned surgical procedure or any coronary revascularisation (surgical or
             percutaneous) planned within 60 days following randomisation

          -  Any known contraindication to treatment with an antiplatelet agent

          -  Significant hypertension at the time of screening or randomisation

          -  Clinically significant out-of-range values for platelet count or haemoglobin at
             screening, in the investigator's opinion, or results of clinical laboratory tests at
             the time of screening that are judged to be clinically significant for the study
             population, as determined by the investigator

          -  Prior history or presence of significant bleeding disorders, abnormal bleeding
             tendency, or personal history of coagulation or bleeding disorders.

          -  Prior history or clinical suspicion of cerebral vascular malformations, intracranial
             neoplasm, Transient Ischemic Attack (TIA) or stroke.

          -  Prior history of thrombocytopenia or thrombocytosis

          -  Use of antiplatelet agents (besides aspirin) within 10 days prior to screening; the
             use (or planned use) of heparin, oral anticoagulants, or fibrinolytic agents within 30
             days of screening; or subjects receiving daily treatment with nonsteroidal
             anti-inflammatory drugs (NSAIDS) or cyclooxygenase-2 (COX-2) inhibitors that cannot be
             discontinued for the duration of the study