Effect of Abrupt Plavix® Discontinuation on Platelet Function

NCT00670943 | Completed DMC

• 1 other identifier: C.E. 2007-05-41
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Clopidogrel discontinuation; Platelet aggregation

Study Arms (2)

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

Interventions

Platelet function testing OTHER

A; B

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with stable coronary artery disease

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Montréal: lead
• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal: collaborator

Study Sites (1)

Hôpital du Sacré-Coeur de Montréal

Montreal, Quebec, H4J 1C5, Canada

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Jean G Diodati, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 30, 2008
• First Posted: May 2, 2008
• Study Start: January 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: March 25, 2009

Record last verified: 2009-03

Locations

CA (1)