Study target patients are those with peripheral arterial disease who underwent a major vascular surgery and develop asymptomatic troponine-elevation. These patients are randomised for treatment with clopidogrel or not. Main aim of the study is prevention of cardiac events in pt with peripheral arterial disease. Follow-up is directed at occurrence of cardiovascular events and post-operative bleeding complications. MedDRA version: 9.1 Level: HLT Classification code 10034638 Term: Peripheral vascu
Conditions
Interventions
Trade Name: Plavix
Product Name: plavix
Product Code: Plavix-H-C-174-X-70
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: clopidogrel
CAS Number: 94188848
Other descriptive name: CLOPIDOG
Sponsors
Lijf en Leven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria Men and women who are scheduled for major vascular surgery are eligible for the trial.Eligible patients include those above the age of 18 years and at least one of the following: 1. abdominal aortic aneurysm repair 2. aortic stenosis repair 3. above knee femoropopliteal bypass surgery 4. below knee femoropopliteal bypass surgery. And with postoperative asymptomatic troponin T release without ECG abnormalities. 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: Exclusion Criteria Potential subjects will be excluded with any of the following : 1. Active bleeding 2. Untreated left main disease 3. Active cardiac condition such as unstable angina pectoris, active CHF, serious cardiac arrhythmias, symptomatic valvular disease, recent 3x ULN) 10. cancer with an expected life expectancy < 6 months 11. anticipated non-adherence to clopidogrel 12. excessive alcohol use 13. pregnancy or planning to become pregnant 14. failure to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine whether clopidogrel + best medical treatment is superior to best medical treatment only in preventing: A. cardiovascular death, MI, stroke, or severe ischemia of the coronary or peripheral arterial circulation leading to an intervention. in patients with asymptomatic perioperative troponin release during or shortly (within 30days) after major vascular surgery.;Secondary Objective: Secondary objectives:Secondary objectives include determining the effect of clopidogrel on: B.Bleeding complications, defined as life-threatening bleeding, moderate and minor bleeding. In patients with asymptomatic perioperative troponin release after major vascular surgery.;Primary end point(s): The primary outcome is defined as the composite of cardiovascular death, MI, stroke, or severe ischemia of the coronary or peripheral arterial circulation leading to an intervention. Safety outcomes include life-threatening, moderate bleeding, and minor bleeding are considered as secondary outcome. Tertiary objectives include identification of preoperative risk factors and novel biomarkers of the primary endpoint. | — |
Countries
Netherlands
Outcome results
None listed