Determining Genetic Role in Treatment Response to Anti-Platelet Interventions (The PAPI Study)
Condition: Platelet Aggregation Inhibitors; Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Intervention: Clopidogrel; Aspirin
Intervention description: 300 mg on first day, then 75 mg per day for the next 6 days; Single dose of 324 mg on the last day of clopidogrel treatment
Intervention MeSH terms: Aspirin; Clopidogrel
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 682.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      One of the most common ways for preventing coronary heart disease (CHD) is to take aspirin or
      clopidogrel. However, studies have shown that not all people respond to these medications.
      The variance in treatment response may be linked to genetics. This study will examine the
      effects of aspirin and clopidogrel in a population whose genes are well known in order to
      determine the role that genes play in treatment responses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Of Old Order Amish descent

        Exclusion Criteria:

          -  Currently pregnant or less than 6 months have passed since delivery

          -  Has a history of a bleeding disorder or major spontaneous bleed, such as peptic ulcer,
             epistasis, or intracranial bleed

          -  Has severe hypertension, defined by a blood pressure above 160/95 mm Hg, making it
             unethical not to recommend prompt treatment

          -  Takes medications that would affect the outcome(s) to be measured and cannot willingly
             and safely, in the opinion of the treating physician and study physician, discontinue
             these medications for 1 week prior to protocol initiation

          -  Is taking vitamins or other supplements and is unwilling to discontinue their use for
             at least 1 week prior to study

          -  Has a coexisting malignancy

          -  Has a creatinine level greater than 2.0 mg/dl, aspartate transaminase (AST) or alanine
             transaminase (ALT) greater than two times the upper limit of normal, hematocrit less
             than 32%, or a thyroid-stimulating hormone (TSH) less than 0.4 or greater than 5.5
             mIU/L

          -  Has a bleeding disorder or history of gastrointestinal bleeding or other major
             bleeding episode

          -  Is currently taking aspirin, clopidogrel, or other anti-coagulant, such as warfarin,
             heparin, or GPIIb/IIIa antagonists, and have conditions that might place them at
             increased risk from withdrawal of these medications 14 days prior to protocol
             initiation, including history of unstable angina, heart attack, angioplasty (including
             stent placement), coronary artery bypass surgery, atrial fibrillation, stroke or
             transient ischemic attacks, diabetes, or deep vein thrombosis or other thrombosis

          -  Has polycythemia, or thrombocytosis, defined by a platelet count greater than 500,000

          -  Has thrombocytopenia, defined by a platelet count less than 75,000

          -  Has had surgery within the last 6 months

          -  Has an aspirin or clopidogrel allergy

          -  Currently breast feeding