Is cessation of clopidogrel therapy associated with rebound of platelet activity in stable vascular disease patients?

Completed

Conditions: Cardiovascular and peripheral vascular disease
Circulatory System
Atherosclerosis

Registration Number: ISRCTN77887299

Lead Sponsor: Grampian Health Board and University of Aberdeen (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 156

Inclusion Criteria

1. Both males and females, age 30-80 years
2. Evidence of chronic atherosclerotic disease - stable coronary heart disease or peripheral arterial disease
3. Already receiving standard secondary prevention therapy for cardiovascular disease, including aspirin therapy and a statin
4. Able to give informed consent

Exclusion Criteria

1. Known allergy to clopidogrel
2. Contraindications to clopidogrel as listed in the Summary of Product
3. Characteristics for clopidogrel (i.e Hypersensitivity to the active substance or to any of the excipients of the medicinal product, severe liver impairment, active pathological bleeding such as peptic ulcer or intracranial haemorrhage, breast feeding)
Also:
4. History of thrombocytopenia, neutropenia or haematological malignancy
5. Bleeding diathesis
6. Abnormal renal or hepatic function
7. Transfusion of whole blood cells within 14 days prior to randomisation
8. Known or suspected drug or alcohol abuse
9. Clinical symptoms of heart failure
10. Women of child-bearing potential
11. Taking anticoagulant or antiplatelet drugs other than aspirin
12. Participation in another clinical trial of a medicinal product (CTIMP) within preceding 3 months

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement of platelet activation and aggregation, before treatment, on clopidogrel/placebo, and at 7, 14 and 28 days after cessation of clopidogrel/placebo.

Secondary Outcome Measures

Name	Time	Method
The following inflammatory and procoagulant markers will be assessed before treatment, on clopidogrel/placebo, and at 7, 14 and 28 days after cessation of clopidogrel/placebo:<br>1. High-sensitivity C-reactive protein (hs-CRP)<br>2. D-Dimer<br>3. Soluble CD40 (sCD40) ligand<br>4. Soluble P-selectin (sP-selectin)<br> <br>While the primary aim of this study is not to measure clinical outcome, such data will be collected in order to inform a later multi-centre clinical outcome study.