- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H4J 1C5
- Hôpital du Sacré-Coeur de Montreal
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
A
Patients with stable CAD with scheduled discontinuation of clopidogrel
|
|
B
Patients with stable CAD not taking clopidogrel
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C.E. 2007-05-41
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Artery Disease
-
Elixir Medical CorporationIstituto Clinico HumanitasActive, not recruitingCoronary Artery Disease | Chronic Total Occlusion of Coronary Artery | Multi Vessel Coronary Artery Disease | Bifurcation of Coronary Artery | Long Lesions Coronary Artery DiseaseItaly
-
Fundación EPICActive, not recruitingCoronary Artery Disease | Left Main Coronary Artery Disease | Left Main Coronary Artery Stenosis | Restenosis, CoronarySpain
-
Peking Union Medical College HospitalNot yet recruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
Peking Union Medical College HospitalRecruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
IGLESIAS Juan FernandoUniversity of BernNot yet recruiting
-
National Institutes of Health Clinical Center (CC)National Heart, Lung, and Blood Institute (NHLBI)CompletedCoronary Arteriosclerosis | Coronary Artery Disease (CAD) | Obstructive Coronary Artery DiseaseUnited States
-
Barts & The London NHS TrustImperial College London; Brunel UniversityNot yet recruitingCORONARY ARTERY DISEASE
-
Fundación EPICRecruitingCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Left Main Coronary Artery Disease | Coronary Artery StenosisSpain
-
Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Chronic Total Occlusion of Coronary Artery | Coronary Restenosis | Coronary Artery Stenosis | Coronary Artery RestenosisBelgium
-
China National Center for Cardiovascular DiseasesRecruitingLeft Main Coronary Artery DiseaseChina
Clinical Trials on Platelet function testing
-
Vanderbilt University Medical CenterMassachusetts General Hospital; Carelon ResearchActive, not recruitingDiabetes Mellitus | Peripheral Arterial DiseaseUnited States, Canada, Finland
-
Milton S. Hershey Medical CenterCompleted
-
Christiana Care Health ServicesCompletedRespiratory InsufficiencyUnited States
-
Sohag UniversityNot yet recruitingExecutive Dysfunction | Stuttering, ChildhoodEgypt
-
Memorial Sloan Kettering Cancer CenterCompletedHigh Risk for Postoperative Cardiovascular EventsUnited States
-
University of RostockCompletedSARS-CoV-2 InfectionGermany
-
Hasselt UniversityJessa HospitalCompletedDiabetes Mellitus, Type 1Belgium
-
Milton S. Hershey Medical CenterALS AssociationRecruiting
-
CNSystems Medizintechnik GmbHNot yet recruitingOrthostatic Intolerance | Autonomic Dysfunction
-
Danish Pain Research CenterMayo Clinic; Aalborg UniversityCompletedAutonomic Nervous System DiseasesDenmark