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Effect of Abrupt Plavix® Discontinuation on Platelet Function

This study is currently recruiting participants.
Verified by University of Montreal, April 2008

Sponsors and Collaborators: University of Montreal
Hôpital du Sacré-Coeur de Montréal
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

MedlinePlus related topics:   Coronary Artery Disease   

ChemIDplus related topics:   Clopidogrel    Clopidogrel Bisulfate   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective
Official Title:   Effect of Abrupt Plavix® Discontinuation on Platelet Function

Further study details as provided by University of Montreal:

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
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

Contacts
Contact: Jean G Diodati, MD     jean.gino.diodati@umontreal.ca    

Locations
Canada, Quebec
Hôpital du Sacré-Coeur de Montréal     Recruiting
      Montreal, Quebec, Canada, H4J 1C5

Sponsors and Collaborators
University of Montreal
Hôpital du Sacré-Coeur de Montréal

Investigators
Principal Investigator:     Jean G Diodati, MD     Hôpital du Sacré-Coeur de Montréal    
  More Information


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

Keywords provided by University of Montreal:
Clopidogrel discontinuation  
Platelet aggregation  

Study placed in the following topic categories:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Clopidogrel
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 10, 2008




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