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
Conditions
Interventions
Trade Name: Plavix
Product Name: Plavix
Product Code: Plavix
Pharmaceutical Form: Capsule*
INN or Proposed INN: CLOPIDOGREL BISULPHATE
Sponsors
University of Aberdeen
NHS Grampian Health Board
Eligibility
Sex/Gender
All
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim of this study is to identify whether there is evidence for a "rebound" effect on platelet markers associated with cessation of clopidogrel therapy. We propose to address this in patients with stable cardiovascular disease by means of a mechanistic study. ; Secondary Objective: We will also assess the effect of withdrawal of clopidogrel on inflammatory and procoagulant markers as another possible mechanism for increased risk of cardiovascular ischaemic events. While the primary aim of this study is not to measure clinical outcome, these data will be collected for a period of 6 months following completion of the study. ; Primary end point(s): The primary endpoint will be a rebound effect (?A) in platelet response to stimulation, within the clopidogrel treatment group compared with the placebo group. ?A is calculated by subtracting the subject's platelet activity at baseline (A(tb)) from the activity at follow-up (A(tf)). We will also compare the mean ?A in the clopidogrel treatment group with the mean in the placebo group using unpaired t-tests . ?A is expected to be close to zero in the placebo group but these patients are included to control for any unexpected shift in patient response. | — |
Countries
United Kingdom
Outcome results
None listed