Effect of Abrupt Plavix® Discontinuation on Platelet Function
Information source: University of Montreal
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Artery Disease
Intervention: Platelet function testing (Other)
Phase: N/A
Status: Recruiting
Sponsored by: University of Montreal Official(s) and/or principal investigator(s):
Jean G Diodati, MD, Principal Investigator, Affiliation: Hôpital du Sacré-Coeur de Montréal
Overall contact:
Jean G Diodati, MD, Email: jean.gino.diodati@umontreal.ca
Summary
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.
Clinical Details
Official title: Effect of Abrupt Plavix® Discontinuation on Platelet Function
Study design: Cohort, Prospective
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
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
Locations and Contacts
Jean G Diodati, MD, Email: jean.gino.diodati@umontreal.ca
Hôpital du Sacré-Coeur de Montréal, Montreal, Quebec H4J 1C5, Canada; Recruiting
Additional Information
Starting date: January 2008
Ending date: December 2008
Last updated: May 1, 2008
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