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

NCT ID: NCT01011257

Last Updated: 2018-01-31

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-09-30

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aspirin 81 mg, 1 tab twice daily

All participants to take one aspirin (81mg per tab) twice daily.

Group Type: ACTIVE_COMPARATOR

Asprin

Intervention Type: DRUG

asprin 81mg, 1 tab, twice daily OR aspirin 81mg, 2 tab, once daily

Clopidogrel 75 mg 1 tab daily

Only stable CAD participants will take Clopidogrel (75mg per tab) daily.

Group Type: ACTIVE_COMPARATOR

Clopidogrel

Intervention Type: DRUG

clopidogrel 75 mg bid

Interventions

Asprin

asprin 81mg, 1 tab, twice daily OR aspirin 81mg, 2 tab, once daily

Intervention Type: DRUG

Clopidogrel

clopidogrel 75 mg bid

Intervention Type: DRUG

Other Intervention Names

ASA; Plavix

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.
• We will also exclude patients with unstable angina and recent (less than a month) CABG or PCTA.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Neil Kleiman, MD

OTHER

Sponsor Role: lead

Responsible Party

Neil Kleiman, MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Neal S Kleiman, MD

Role: PRINCIPAL_INVESTIGATOR

Methodist DeBakey Heart Center.

Locations

The Methodist Hospital

Houston, Texas, United States

Countries

United States

Other Identifiers

Pro00001863

Identifier Type: -

Identifier Source: org_study_id