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Sponsors and Collaborators: |
University of Montreal Hôpital du Sacré-Coeur de Montréal |
Information provided by: | University of Montreal |
ClinicalTrials.gov Identifier: | NCT00670943 |
The well established importance of regular administration of antiplatelet drugs stands on firm grounds, as large meta-analyses have shown these therapies to significantly reduce the risk of death. Plavix® (clopidogrel) is widely used following coronary angioplasty, to reduce the risk of periprocedural thrombotic complications, for up to one year. As the current recommendations suggest clopidogrel use for no longer than one year, the drug is normally discontinued within that period. In the limited state of knowledge on antiplatelet drug withdrawal, an early sound of alarm has risen from early thromboembolic complications reported after the interruption of antiplatelet treatment used in prevention of ischemic vascular disease. Although little information is available, discontinuation of thienopyridines has been associated with increased thromboembolic complications, mainly acute stent thrombosis. These complications may signal a platelet sensitization effect to aggregating stimuli by antiplatelet drugs taken chronically.
The current study aims to evaluate the impact of clopidogrel discontinuation on platelet function, in order to shed light on underlying mechanisms leading to increased risk of acute thrombo-occlusive events.
Condition | Intervention |
Coronary Artery Disease |
Other: Platelet function testing |
MedlinePlus related topics: | Coronary Artery Disease |
ChemIDplus related topics: | Clopidogrel Clopidogrel Bisulfate |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Effect of Abrupt Plavix® Discontinuation on Platelet Function |
Estimated Enrollment: | 52 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
A
Patients with stable CAD with scheduled discontinuation of clopidogrel
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Other: Platelet function testing |
B
Patients with stable CAD not taking clopidogrel
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Other: Platelet function testing |
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Patients with stable coronary artery disease
Inclusion Criteria:
Exclusion Criteria:
Contact: Jean G Diodati, MD | jean.gino.diodati@umontreal.ca |
Canada, Quebec | |||||
Hôpital du Sacré-Coeur de Montréal | Recruiting | ||||
Montreal, Quebec, Canada, H4J 1C5 |
University of Montreal |
Hôpital du Sacré-Coeur de Montréal |
Principal Investigator: | Jean G Diodati, MD | Hôpital du Sacré-Coeur de Montréal |
Responsible Party: | Hôpital du Sacré-Coeur de Montréal ( Jean G. Diodati ) |
Study ID Numbers: | C.E. 2007-05-41 |
First Received: | April 30, 2008 |
Last Updated: | May 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00670943 |
Health Authority: | Canada: Ethics Review Committee |
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