Patients with coronary artery disease requiring coronary artery bypass grafting (CABG) are at risk for postoperative complications after surgery. The StaRT-CABG trial is the first large-scale (2,630 patients) that will investigate whether an additional treatment with statins (lipid-lowering medication) in high doses before CABG surgery can reduce the incidence of major post-surgery complications including death, myocardial infarction and stroke. The StaRT-CABG trial will be recruiting patients from 8 cardiac surgery centres in Germany and is expected to provide relevant clinical data on the efficacy of this novel treatment in order to optimize the care for all patients undergoing CABG.
Patients with coronary artery disease (CAD) requiring coronary artery bypass grafting (CABG) are still at significant risk for postoperative major adverse cardiocerebral events (≈15% MACCE rate), with ≈3% of patients dying within 30 days of surgery. Recent clinical evidence shows that cardioprotection in patients receiving chronic statin treatment can be further improved by a high-dose statin 'recapture' therapy given shortly before an ischemia-reperfusion sequence, resulting in a 61% risk reduction for MACE at 30 days in patients undergoing PCI. Evaluation of this novel approach in the setting of CABG seems particularly promising, as myocardial injury, surgery-related inflammation and pre-existing patients' comorbidities play a pivotal role for poor clinical outcomes after CABG that may be improved by an acute statin recapture therapy. The StaRT-CABG trial is the first large-scale (n=2,630 CABG patients), multicentre (8 cardiac surgery centres), randomised, double-blind and placebo-controlled trial that aims to test whether an acute high-dose statin recapture therapy given shortly before CABG reduces the incidence of MACCE at 30 days after surgery (composite primary outcome: all-cause mortality; non-fatal myocardial infarction and cerebrovascular events). The StaRT-CABG trial is expected to provide highly relevant clinical data on the efficacy of this novel therapeutic approach in order to optimize the care for all CAD patients undergoing CABG with broad clinical implications on current clinical practice and existing guidelines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2,630
Given 12h and 2h before CABG
Given 12h and 2h before CABG.
Heart Center Freiburg-Bad Krozingen
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Heart Center Bad Neustadt
Bad Neustadt an der Saale, Bavaria, Germany
University of Aachen
Aachen, North Rhine-Westphalia, Germany
Heart Center Bad Oeynhausen
Bad Oeynhausen, North Rhine-Westphalia, Germany
University of Bochum
Bochum, North Rhine-Westphalia, Germany
University of Bonn
Bonn, North Rhine-Westphalia, Germany
University of Cologne
Cologne, North Rhine-Westphalia, Germany
University of Essen
Essen, North Rhine-Westphalia, Germany
University of Muenster
Münster, North Rhine-Westphalia, Germany
Helios Heart Center Wuppertal
Wuppertal, North Rhine-Westphalia, Germany
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).
Time frame: 30 days after Surgery
Major adverse cardiac events
Composite outcome consisting cardiac mortality and non-fatal MI within 30 days after surgery.
Time frame: 30 days after Surgery
Length of stay
Length of stay on intensive care unit (ICU) and hospital
Time frame: within the first 15 days after surgery (plus or minus 5 days)
Repeat coronary revascularisation
Repeat coronary revascularisation (PCI or CABG)
Time frame: 30 days after surgery
Mortality at 12 months
All-cause mortality at 12 months
Time frame: 12 months after surgery
Wound Infections
Surgical site wound infections.
Time frame: 30 days after surgery
Atrial fibrillation
New-onset postoperative atrial fibrillation
Time frame: within the first 15 days after surgery (plus or minus 5 days)
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