Methods to Augment the Efficacy of Aspirin and Clopidogrel in Healthy Subjects and Patients With Stable Coronary Artery Disease With an Elevated Platelet Turnover (Reticulated Platelets) (Dual dosing)
This study has suspended participant recruitment.
(Awaiting further funding.)
Sponsor:
The Methodist Hospital System
Information provided by:
The Methodist Hospital System
ClinicalTrials.gov Identifier:
NCT01011257
First received: November 9, 2009
Last updated: June 28, 2011
Last verified: June 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Drug: Asprin Drug: Clopidogrel |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by The Methodist Hospital System:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | September 2011 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Aspirin 81 mg od |
Drug: Asprin
asprin 81mg bd or 162mg od
|
| Active Comparator: Clopidogrel 75 mg bd |
Drug: Clopidogrel
clopidogrel 75 mg bd
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01011257
Locations
| United States, Texas | |
| The Methodist Hospital | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
The Methodist Hospital System
Investigators
| Principal Investigator: | Neal S Kleiman, MD | Methodist DeBakey Heart Center. |
More Information
No publications provided
| Responsible Party: | Neal S Kleiman, MD, Methodist DeBakey Heart center, Methodist Hospital |
| ClinicalTrials.gov Identifier: | NCT01011257 History of Changes |
| Other Study ID Numbers: | IRB0508-0069 |
| Study First Received: | November 9, 2009 |
| Last Updated: | June 28, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by The Methodist Hospital System:
|
CAD |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Clopidogrel Platelet Aggregation Inhibitors |
Hematologic Agents Therapeutic Uses Pharmacologic Actions Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013