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Effect of Abrupt Plavix® Discontinuation on Platelet Function

This study has been completed.
Sponsor:
Collaborator:
Hopital du Sacre-Coeur de Montreal
Information provided by:
Université de Montréal
ClinicalTrials.gov Identifier:
NCT00670943
First received: April 30, 2008
Last updated: March 24, 2009
Last verified: March 2009
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Université de Montréal:

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
Study Population

Patients with stable coronary artery disease

Criteria

Inclusion Criteria:

  • Group 1: Patients suffering from stable CAD scheduled to discontinue clopidogrel therapy at least one month after stent implantation
  • Group 2: Stable clopidogrel-naïve CAD patients
  • Patients willing to participate in the study and to sign the informed consent form

Exclusion Criteria:

  • Acute coronary syndrome or revascularization in the last 3 months prior to enrolment
  • Concurrent ingestion of nonsteroidal anti-inflammatory drugs (NSAIDs, including COX-2 selective anti-inflammatory drugs), ticlopidine, dipyridamole, warfarin or acenocoumarol
  • Major surgical procedure within 1 month before enrolment
  • Platelet count outside the 100 000 to 450 000/μL range
  • Hematocrit < 25% or haemoglobin < 100 g/L
  • Patient undergoing dialysis for chronic renal failure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00670943

Locations
Canada, Quebec
Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, Canada, H4J 1C5
Sponsors and Collaborators
Université de Montréal
Hopital du Sacre-Coeur de Montreal
Investigators
Principal Investigator: Jean G Diodati, MD Hopital du Sacre-Coeur de Montreal
  More Information

No publications provided

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

Keywords provided by Université de Montréal:
Clopidogrel discontinuation
Platelet aggregation

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 23, 2013