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

Conditions: 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: 9.1Level: HLTClassification code 10034638Term: Peripheral vascular disorders NEC
MedDRA version: 9.1Level: LLTClassification code 10018106Term: Generalized arterial disease

Registration Number: EUCTR2008-004016-12-NL

Lead Sponsor: ijf en Leven

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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 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 < 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