Clinical trial NCT01011257: Studying the Efficacy of Aspirin & Clopidogrel in Healthy Subjects With Stable Coronary Artery Disease.
Official title: Methods to Augment the Efficacy of Aspirin and Clopidogrel in Healthy Subjects (ASA Only) and Patients With Stable Coronary Artery Disease (Taking Clopidogrel Only) or (Taking Clopidogrel & ASA) With an Elevated Platelet Turnover (Reticulated Platelets).
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: CAD
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2009-11-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators will test the hypothesis that aspirin or clopidogrel taken twice daily will augment their antiplatelet efficacy in patients with an elevated platelet turnover (as measured by the proportion of reticulated (young) platelets) compared with once daily dosing.

Detailed description: 1. To study whether in healthy subjects with an increased platelet turnover, a twice daily dosing of aspirin 81 mg will be more effective in inhibiting platelets compared with once a day aspirin 81 mg.
2. To study whether in patients with stable coronary artery disease (CAD) with an increased platelet turnover, a twice daily dosing of aspirin 81 mg will be more effective in inhibiting platelets compared with once a day aspirin 81 mg.
3. To study whether in healthy subjects with an increased platelet turnover, a twice daily dosing of aspirin 81 mg and clopidogrel 75 mg will be more effective in inhibiting platelets compared with once daily of both aspirin and clopidogrel.
4. To study whether in patients with stable coronary artery disease (CAD), increased platelet turnover and aspirin resistance, an oral fatty acid (docosahexaenoic acid (DHA) and eicosapentanoic acid (EPA), 4 gm/day) supplementation will increase the efficacy of aspirin by modifying platelet function compared to once a day aspirin 81 mg.

Eligibility criteria: Inclusion Criteria:

* Group A: Healthy subjects aged 18-64 years with no evidence of coronary artery disease or any major risk factors for CAD including smoking, diabetes mellitus, hyperlipidemia, hypertension and obesity.
* Group B: Patients with known CAD aged 18-64 years taking aspirin 81 mg daily as the only antiplatelet therapy. Patients should be in stable condition and at least one month post myocardial infarction.
* Group C: Patients with known stable CAD aged 18-64 years taking aspirin 81 mg and clopidogrel 75 mg daily. Patients should be in stable condition and at least one month post myocardial infarction.

Exclusion Criteria:

* Subjects will be excluded if they used NSAID's within one week prior to the study, have renal insufficiency, inflammatory disorders such as rheumatologic conditions, autoimmune disorders, active infections, malignancy or if they are undergoing chemotherapy.
* Other exclusion criteria include contraindications to aspirin including active bleeding, hypersensitivity, thrombocytopenia (platelet count \< 50,000) and anemia (hemoglobin \< 10.0 gm/dl).
* We will also exclude patients with unstable angina and recent (less than a month) CABG or PCTA.

Primary outcomes:
measure: To look if dual dosing of aspirin and/or clopidogrel will augment antiplatelet efficacy in patients with elevated reticulated platelet turnover.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
Study officials:
affiliation: Methodist DeBakey Heart Center.
name: Neal S Kleiman, MD
role: PRINCIPAL_INVESTIGATOR
References: