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Sponsored by: |
Creighton University |
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Information provided by: | Creighton University |
ClinicalTrials.gov Identifier: | NCT00589862 |
It is recommended that patients who have drug-eluting stents placed in their coronary arteries take aspirin and Plavix (Clopidogrel) for at least a year.
Patients who stop taking these antiplatelet drugs or who have resistance to the antiplatelet effects of these drugs are at a higher risk of clots occurring inside the stents which may result in a heart attack. At the present time, it is unknown if increasing the doses of the antiplatelet agents is effective in overcoming this resistance. The purpose of this project is to identify patients with antiplatelet drug resistance and to test whether an increase in the Plavix (Clopidogrel) dose overcomes antiplatelet drug resistance.
Condition | Intervention | Phase |
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Coronary Artery Disease |
Drug: Plavix (Clopidogrel) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
Estimated Enrollment: | 200 |
Study Start Date: | October 2007 |
Study Completion Date: | July 2008 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Plavix (Clopidogrel)
150 mg tablet of Plavix (Clopidogrel) per day for 12 months if resistance is identified
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Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Nebraska | |
Creighton University Medical Center | |
Omaha, Nebraska, United States, 68131 |
Principal Investigator: | Daniel Hilleman, PharmD | Creighton University |
Responsible Party: | Creighton University ( Daniel Hilleman, PharmD ) |
Study ID Numbers: | 07-14622, 07-14622 |
Study First Received: | December 28, 2007 |
Last Updated: | July 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00589862 History of Changes |
Health Authority: | United States: Institutional Review Board |
Drug Eluting Stents Clopidogrel Resistance Aspirin Resistance |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Aspirin Clopidogrel Myocardial Ischemia |
Vascular Diseases Platelet Aggregation Inhibitors Arteriosclerosis Ischemia Coronary Artery Disease |
Arterial Occlusive Diseases Heart Diseases Myocardial Ischemia Hematologic Agents Vascular Diseases Arteriosclerosis Pharmacologic Actions |
Coronary Disease Clopidogrel Therapeutic Uses Cardiovascular Diseases Platelet Aggregation Inhibitors Coronary Artery Disease |