Statin Recapture Therapy before Coronary Artery Bypass Grafting.
- Conditions
- I25.1Atherosclerotic heart disease
- Registration Number
- DRKS00000753
- Lead Sponsor
- niversitätsklinikum Köln
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 2630
Key inclusion criteria:
1. Patients on chronic statin treatment (>30 days) scheduled for isolated
CABG, including on- or off-pump or repeat (redo’s) revascularisation
procedures
2. Stable or unstable angina, including non ST-segment-elevation acute
coronary syndrome (NSTE-ACS)
3. Age = 18 years
4. Written informed consent
Key exclusion criteria:
1. Any concomitant cardiovascular procedure to CABG (i.e. valve, aortic or
carotid surgery)
2. Acute ST-segment-elevation myocardial infarction (STEMI)
3. NSTE-ACS with cardiogenic shock warranting emergent salvage surgery within 12 hrs from hospital admission
4. History of atrial fibrillation or muscle disease (myopathy)
5. Current renal (creatinine>2x ULN, dialysis, kidney transplant) or hepatic
dysfunction (AST/ALT>2x ULN, liver transplant or neoplasm)
6. Inability of oral drug intake
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary efficacy endpoint:<br>Major adverse cardiocerebral events (MACCE) within 30 days after CABG.<br>Composite endpoint consisting of:<br>(1) all-cause mortality, (2) non-fatal myocardial infarction (MI) and (3) non-fatal<br>cerebrovascular event (stroke or TIA)
- Secondary Outcome Measures
Name Time Method 1. Major adverse cardiac events: cardiac mortality and non-fatal MI within 30<br>days<br>2. New-onset atrial fibrillation<br>3. Postoperative enzymatic myocardial injury (troponin T, CK-MB)<br>4. Length of stay on intensive care unit (ICU) and hospital<br>5. Repeat coronary revascularisation<br>6. All-cause mortality at 12 months