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Effect of Abrupt Plavix® Discontinuation on Platelet Function

Effect of Abrupt Plavix® Discontinuation on Platelet Function

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00670943
Enrollment
52
Registered
2008-05-02
Start date
2008-01-31
Completion date
2009-03-31
Last updated
2009-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Clopidogrel discontinuation, Platelet aggregation

Brief 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.

Interventions

Sponsors

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
CollaboratorOTHER
Université de Montréal
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026