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

Sponsor

Neil Kleiman, MD (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01011257

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Drug: Asprin Drug: Clopidogrel	Phase 4

Detailed Description

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.
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.
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.
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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Aug 1, 2011

Actual Study Completion Date :

Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Aspirin 81 mg, 1 tab twice daily All participants to take one aspirin (81mg per tab) twice daily.	Drug: Asprin asprin 81mg, 1 tab, twice daily OR aspirin 81mg, 2 tab, once daily Other Names: ASA
Active Comparator: Clopidogrel 75 mg 1 tab daily Only stable CAD participants will take Clopidogrel (75mg per tab) daily.	Drug: Clopidogrel clopidogrel 75 mg bid Other Names: Plavix

Arm

Intervention/Treatment

Active Comparator: Aspirin 81 mg, 1 tab twice daily

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

Drug: Asprin

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

Other Names:

ASA

Active Comparator: Clopidogrel 75 mg 1 tab daily

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

Drug: Clopidogrel

clopidogrel 75 mg bid

Other Names:

Plavix

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Methodist Hospital	Houston	Texas	United States	77030

Sponsors and Collaborators

Neil Kleiman, MD

Investigators

Principal Investigator: Neal S Kleiman, MD, Methodist DeBakey Heart Center.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Neil Kleiman, MD, Principal Investigator, The Methodist Hospital Research Institute

ClinicalTrials.gov Identifier:

NCT01011257

Other Study ID Numbers:

Pro00001863

First Posted:

Nov 11, 2009

Last Update Posted:

Jan 31, 2018

Last Verified:

Jan 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Neil Kleiman, MD, Principal Investigator, The Methodist Hospital Research Institute

CAD

Additional relevant MeSH terms:

Coronary Artery Disease

Myocardial Ischemia

Coronary Disease

Clopidogrel

Study Results

No Results Posted as of Jan 31, 2018