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| Sponsor: | University of Montreal |
|---|---|
| Collaborator: |
Hopital du Sacre-Coeur de Montreal |
| Information provided by: | University of Montreal |
| ClinicalTrials.gov Identifier: | NCT00670943 |
Purpose
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 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Effect of Abrupt Plavix® Discontinuation on Platelet Function |
| Estimated Enrollment: | 52 |
| Study Start Date: | January 2008 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
A
Patients with stable CAD with scheduled discontinuation of clopidogrel
|
Other: Platelet function testing |
|
B
Patients with stable CAD not taking clopidogrel
|
Other: Platelet function testing |
Eligibility| 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:
Contacts and Locations| Canada, Quebec | |
| Hôpital du Sacré-Coeur de Montréal | |
| Montreal, Quebec, Canada, H4J 1C5 | |
| Principal Investigator: | Jean G Diodati, MD | Hopital du Sacre-Coeur de Montreal |
More Information
| Responsible Party: | Jean G. Diodati, Hôpital du Sacré-Coeur de Montréal |
| ClinicalTrials.gov Identifier: | NCT00670943 History of Changes |
| Other Study ID Numbers: | C.E. 2007-05-41 |
| Study First Received: | April 30, 2008 |
| Last Updated: | March 24, 2009 |
| Health Authority: | Canada: Ethics Review Committee |
|
Clopidogrel discontinuation Platelet aggregation |
|
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 |