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OpenTrials
Completed

NCT Number: NCT00670943

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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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital du Sacré-Coeur de Montréal

Montreal, Quebec, H4J 1C5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet function testing

Other

Sponsors and collaborators

Lead sponsor

Université de Montréal

Other

Collaborators

  • Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 2, 2008
Registry last updated
Mar 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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