English: Clopidogrel Cardiac complications Vascular surgery Dutch: Clopidogrel Cardiale complicaties Vaatoperaties
Conditions
Interventions
Randomisation for use of clopidogrel on top of standard treatment with aspirin or use of aspirin only. Randomisation is executed after the patient develops an asymptomatic troponin T release during th
Sponsors
Stichting Lijf en Leven
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age above 18 years 2. Patients scheduled for major vascular surgery, one of the following: - Abdominal aortic aneurysm repair - Aortic stenosis repair - Femoropopliteal bypass surgery, above and below knee
Exclusion criteria
Exclusion criteria: 1. Active bleeding 2. Untreated left main disease 3. Active cardiac condition such as unstable angina pectoris, 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 |
|---|---|
| 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 after major vascular surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactD. Poldermans
Erasmus MC Department of Anesthesiology
Outcome results
None listed