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Effect of Abrupt Plavix® Discontinuation on Platelet Function

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ClinicalTrials.gov Identifier: NCT00670943
Recruitment Status : Completed
First Posted : May 2, 2008
Last Update Posted : March 25, 2009
Sponsor:
Collaborator:
Hopital du Sacre-Coeur de Montreal
Information provided by:
Université de Montréal

April 30, 2008
May 2, 2008
March 25, 2009
January 2008
March 2009   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00670943 on ClinicalTrials.gov Archive Site
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Effect of Abrupt Plavix® Discontinuation on Platelet Function
Effect of Abrupt Plavix® Discontinuation on Platelet Function

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
Patients with stable coronary artery disease
Coronary Artery Disease
Other: Platelet function testing
  • A
    Patients with stable CAD with scheduled discontinuation of clopidogrel
    Intervention: Other: Platelet function testing
  • B
    Patients with stable CAD not taking clopidogrel
    Intervention: Other: Platelet function testing
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
Same as current
March 2009
March 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00670943
C.E. 2007-05-41
Yes
Not Provided
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Jean G. Diodati, Hôpital du Sacré-Coeur de Montréal
Université de Montréal
Hopital du Sacre-Coeur de Montreal
Principal Investigator: Jean G Diodati, MD Hopital du Sacre-Coeur de Montreal
Université de Montréal
March 2009