arteriosclerosis and trombosis
Conditions
Interventions
Patients will be randomized to receive either clopidogrel or placebo on top of
standard treatment with aspirin for 12 months postoperatively, in case of
postoperative troponin elevation, above the 9
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1.Preoperative myocardial injury (baseline value), defined as a troponin release above 99th percentile. 2.Absence of significant occlusive coronary artery disease as diagnosed through angiography (and confirmed by FFR). 3.Postoperative myocardial injury, defined as troponin release above the 99th percentile, which exceed the baseline value.
Exclusion criteria
Exclusion criteria: 1. if troponin elevation is diagnosed as myocardial infarction by cardiologist. 2. Presence of significant occlusive coronary artery disease, as diagnosed through preoperative angiography, requiring treatment. 3. No postoperative troponin values above the 99th percentile and no rise with respect to baseline value. 4. Active bleeding. 5. Active cardiac conditions at the time of randomisation such as unstable angina pectoris, active congestive heart failure (CHF), serious cardiac arrhythmias, symptomatic valvular disease. 6. Clear indication for long-term P2Y12 inhibitor use. 7. Preoperative use of P2Y12 inhibitors. 8. Previous allergy or intolerance to clopidogrel. 9. Use of oral anticoagulants after surgery. 10. Use of intravenous glycoprotein IIB/IIA receptor inhibitors in the previous three days. 11. Coronary revascularization therapy in the previous six months. 12. Renal failure requiring dialysis. 13. Significant liver disease (i.e. ALAT, ASAT > 3x ULN). 14. Cancer with an expected life expectancy less than 6 months. 15. Excessive alcohol use. 16. No informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In patients with asymptomatic troponin release BEFORE and AFTER major vascular surgery the following objectives will be investigated: The primary objective is to assess the efficacy of clopidogrel, as compared to placebo, on top of standard treatment with aspirin on; A. the composite endpoint of MACE, defined as; - cardiovascular death - non-fatal myocardial infarction - stroke - severe ischemia of the coronary or peripheral arterial circulation leading to intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives B. Individual components of MACE C. Bleeding complications, defined as life-threatening bleeding, moderate and minor bleeding. In patients with asymptomatic troponin release BEFORE major vascular surgery the following objective will be investigated: Tertiairy objectives In all patients undergoing vascular surgery and preoperative troponin release, the following objectives will be determinded; D. Presence of significant occlusive coronary artery disease and the impact of presence of vulnerable plaques according to PROSPECT criteria | — |
Countries
Netherlands
Outcome results
None listed