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

Phase 1

• Conditions: Cardiovascular disease; MedDRA version: 9.1 Level: HLT Classification code 10035523 Term: Platelet analyses; MedDRA version: 9.1 Level: LLT Classification code 10007648 Term: Cardiovascular disease, unspecified

• Registration Number: EUCTR2007-007638-21-GB
• Lead Sponsor: niversity of Aberdeen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-07-25
• Study Completion: 2012-07-24
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 172

Inclusion Criteria

Patients aged between 30-80 yrs with evidence of chronic atherosclerotic disease - stable coronary heart disease or peripheral arterial disease. All subjects will already be receiving standard secondary preventive therapy including aspirin therapy and a statin.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will be excluded if they have a known allergy to clopidogrel, have a history of thrombocytopenia, neutropenia, haematological malignancy, abnormal renal or hepatic function, transfusion of whole blood cells within 14 days prior to randomisation, known or suspected drug or alcohol abuse, bleeding diathesis, or clinical symptoms of heart failure. Women of child-bearing potential will be excluded. Patients taking other antiplatelet drugs other than aspirin, or taking anticoagulant drugs will be excluded.

Concurrent use of proton pump inhibitors (amendment AM005 November 2009).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified