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

January 29, 2018 updated by: Neil Kleiman, MD

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The Methodist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neil Kleiman, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

November 9, 2009

First Submitted That Met QC Criteria

November 10, 2009

First Posted (ESTIMATE)

November 11, 2009

Study Record Updates

Last Update Posted (ACTUAL)

January 31, 2018

Last Update Submitted That Met QC Criteria

January 29, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00001863

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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