Patients on a long term statin therapy with established coronary artery disease (CAD) scheduled for isolated surgical myocardial revascularisation (i.e. CABG)
Conditions
Interventions
Trade Name: SimvaHexal 10 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Simvastatin
CAS Number: 79902-63-9
Other descriptive name: SIMVASTATIN
Concentration unit: mg milligram(s)
Co
Sponsors
University of Cologne
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients on long term statin treatment (=30 days) scheduled for isolated CABG, including on- or off-pump or repeat (redo’s) revascularisation procedures • Stable angina, including non ST-segment-elevation acute coronary syndrome (NSTE-ACS) • Age = 18 years • Written informed consent 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 1315 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1315
Exclusion criteria
Exclusion criteria: • Any concomitant cardiovascular procedure to CABG (i.e. valve, aortic or carotid surgery) Acute ST-segment-elevation myocardial infarction (STEMI) Or NSTE-ACS with cardiogenic shock warranting emergent salvage surgery within 24 hours from hospital admission • History of atrial fibrillation or muscle disease (myopathy) • Current renal (creatinine >2 mg/dL (180 µmol/L), dialysis, kidney transplant)) or hepatic dysfunction (AST or ALT >3x ULN, liver transplant or neoplasm) • Inability of oral drug intake
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of an acute statin reloading strategy in patients receiving long term statin therapy prior to CABG on the reduction of postoperative major adverse cardiocerebral events (MACCE);Secondary Objective: not applicable;Primary end point(s): Major adverse cardiocerebral events (MACCE) within 30 days after CABG. Composite endpoint consisting of: (1) all-cause mortality, (2) non-fatal myocardial infarction (MI) and (3) non-fatal cerebrovascular event (stroke or TIA);Timepoint(s) of evaluation of this end point: 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: All-cause mortality at 12 months All other end points at day 30;Secondary end point(s): • Major adverse cardiac events: cardiac mortality and non-fatal MI within 30 days • New-onset atrial fibrillation • Postoperative enzymatic myocardial injury (troponin T, CK-MB) • Length of stay on intensive care unit (ICU) and hospital • Repeat coronary revascularisation • All-cause mortality at 12 months | — |
Countries
Germany
Contacts
Public ContactPD Dr. med O. J. Liakopoulos
University of Cologne
Outcome results
None listed