Studying the Efficacy of Aspirin & Clopidogrel in Healthy Subjects With Stable Coronary Artery Disease.
Status: | Withdrawn |
---|---|
Conditions: | Peripheral Vascular Disease, Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - 64 |
Updated: | 2/2/2018 |
Start Date: | September 2009 |
End Date: | September 2011 |
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).
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.
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.
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.
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.
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.
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