Studying the Efficacy of Aspirin & Clopidogrel in Healthy Subjects With Stable Coronary Artery Disease.

Phase 4

Withdrawn

• Conditions: Coronary Artery Disease
• Interventions: Drug: Asprin; Drug: Clopidogrel

• Registration Number: NCT01011257
• Lead Sponsor: Neil Kleiman, MD

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.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-11-09
• Study First Submitted QC: 2009-11-10
• Study First Posted: 2009-11-11
• Primary Completion: 2011-08
• Study Completion: 2011-09
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-29
• Last Update Posted: 2018-01-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Aspirin 81 mg, 1 tab twice daily	Asprin	All participants to take one aspirin (81mg per tab) twice daily.
Clopidogrel 75 mg 1 tab daily	Clopidogrel	Only stable CAD participants will take Clopidogrel (75mg per tab) daily.

Primary Outcome Measures

Name	Time	Method
To look if dual dosing of aspirin and/or clopidogrel will augment antiplatelet efficacy in patients with elevated reticulated platelet turnover.	1 year

Trial Locations

Locations (1)

The Methodist Hospital; 🇺🇸 Houston, Texas, United States