Clopidogrel for the prevention of late cardiac events in patients with asymptomatic perioperative acute coronary syndrome.

Phase 3

Completed

• Conditions: Cardiac ischemia / cardiac damage; 10011082; 10003184; 10003216

• Registration Number: NL-OMON32253
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 500

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
3) asymptomatic troponin T release during or after surgery

Exclusion Criteria

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 < 6 months.
4) Preoperative positive troponin T
5) Inability to take clopidogrel orally
6) Clear indication for long-term clopidogrel use
7) Previous allergy or intolerance to clopidogrel
8) Renal failure requiring dialysis
9) Significant liver disease (i.e. ALAT, ASAT >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

Study & Design

• Study Type: Interventional
• Study Design: Not specified