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Clinical Trials/NCT01011257
NCT01011257WithdrawnPhase 4

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).

Neil Kleiman, MD1 site in 1 countryStarted: September 2009Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Withdrawn
Sponsor
Locations
1
Primary Endpoint
To look if dual dosing of aspirin and/or clopidogrel will augment antiplatelet efficacy in patients with elevated reticulated platelet turnover.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 64 Years (Adult)
Sex
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.

Arms & Interventions

Aspirin 81 mg, 1 tab twice daily

Active Comparator

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

Intervention: Asprin (Drug)

Clopidogrel 75 mg 1 tab daily

Active Comparator

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

Intervention: Clopidogrel (Drug)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Neil Kleiman, MD
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Neil Kleiman, MD

Principal Investigator

The Methodist Hospital Research Institute

Study Sites (1)

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