Coronary Artery Disease Clinical Trial
— Dual-DosingOfficial 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).
Verified date | January 2018 |
Source | The Methodist Hospital System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | The Methodist Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Neil Kleiman, MD |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To look if dual dosing of aspirin and/or clopidogrel will augment antiplatelet efficacy in patients with elevated reticulated platelet turnover. | 1 year |
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