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


- candidate number3947
- NTR NumberNTR1436
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-sep-2008
- Secondary IDsNL 22179.078.08 
- Public TitleClopidogrel for the prevention of late cardiac events in patients with asymptomatic perioperative acute coronary syndrome.
- Scientific TitleClopidogrel for the prevention of late cardiac events in patients with asymptomatic perioperative acute coronary syndrome.
- ACRONYMDECREASE VII
- hypothesisClopidogrel is effetive and safe for the prevention of cardiovascular events during follow-up in patients with Perioperative Myocardial Infarction during major vascular surgery.
- Healt Condition(s) or Problem(s) studiedAcute coronary syndrome (ACS), Vascular surgery, Clopidogrel
- Inclusion criteria1. 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 criteria1. Active bleeding
2. Untreated left main disease
3. Active cardiac condition such as unstable angina pectoris, 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
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2008
- planned closingdate1-jun-2013
- Target number of participants750
- InterventionsRandomisation 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 the perioperative period.
- Primary outcomeThe 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 outcomeSecondary 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.
- Timepoints- Troponin T measurement at days 1, 3 and 7 postoperatively.
- Outpatient clinic visits at 30 days, 3, 6, 12 months.
Telephonic or written contact.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. dr. D. Poldermans
- CONTACT for SCIENTIFIC QUERIESProf. dr. D. Poldermans
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Stichting Lijf en Leven
- PublicationsN/A
- Brief summaryRationale:
Clopidogrel on top of standard treatment with aspirin has been proven to be effective and safe for the treatment and prevention of Acute Coronary Syndromes (ACS). In vascular surgical patients who have asymptomatic perioperative myocardial ischemia (PMI) measured by troponin T release no suitable treatment for the prevention of cardiovascular events during follow-up is available.

Objective:
To investigate the efficacy and safety of clopidogrel for the prevention of cardiovascular events during follow-up in patients with PMI during major vascular surgery. Furthermore we obtain to identify new preoperative risk factors and novel biomarkers for the development of cardiovascular events during follow-up after major vascular surgery.

Study design:
The current study has a open randomized intervention design, with a 24 months follow-up. Data and blood sample collection will be done pre-operatively (outpatient clinic), perioperative and 30 days, 3, 6, and 12 months after surgery.

Study population:
The proposed study consists of 750 patients above the age of 18 years who develop asymptomatic troponin T release after elective major vascular surgery defined as: (1) abdominal aortic aneurysm (AAA) repair, (2) aortic stenosis repair, (3) above knee femoropopliteal bypass surgery, and (4) below knee femoropopliteal bypass surgery. The total study time is 4 years, including 3 years patient inclusion and 1 year follow-up of the last included patient.

Intervention:
All patients receive standard medical treatment with aspirin, betablocker, statin and proton pump therapy. If postoperative troponin T elevation is present, patients are randomized either to the clopidogrel group and receive a loading dose of 300mg, followed by a daily dose of 75mg during at least one year. The other group receives the standard medical treatment.

Main study parameters/endpoints:
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 during the first 12 months of the follow-up period. Safety outcomes include life-threatening, moderate bleeding and minor bleeding is considered as secondary outcome. Tertiary objectives include identification of preoperative risk factors and novel biomarkers of the primary endpoint.
- Main changes (audit trail)
- RECORD9-sep-2008 - 22-sep-2008


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