The StaRT-CABG Trial

Patients with coronary artery disease (CAD) requiring coronary artery bypass grafting (CABG) are at significant risk for postoperative major adverse cardiocerebral events (MACE). Clinical evidence shows that MACE rates can be reduced in patients receiving chronic statin treatment by an additional high-dose statin 'recapture' therapy given shortly before an ischemia-reperfusion sequence. This resulted in significant risk reduction for cardiocerebral complications at 30 days in patients undergoing percutaneous corornary interventions (PCI). The StaRT-CABG trial aims to evaluate this novel approach in the setting of CABG, where myocardial injury, surgery-related inflammation and pre-existing patients’ comorbidities play a pivotal role for adverse clinical outcomes after CABG, that may be improved by a statin recapture therapy.

The StaRT-CABG trial is the first large-scale, multicentre, 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 clinical 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.

The StaRT-CABG trial is initiated and organised by the Department of Cardiac Surgery at the Heart Center of the University of Cologne in Germany. The Trial is founded by the German Federal Ministry of Education and Research (Grant No. 01KG1103).

Trial protocol code: Uni-Koeln-1341
German Register for Clinical Trials: 00000753
EudraCT number: 2011-001795-19
Clinicaltrials.gov Identifier: NCT01715714 

Contact Information

Principal Investigator
Prof. Dr. Oliver J. Liakopoulos
Dept. of Cardiothoracic Surgery, Heart Center
Kerpener Str. 62, 50937 Cologne, Germany
Email start-cabg@uk-koeln.de

Project Managment
Dipl. Ges.-Ök. Meike Thurat
StaRT-CABG Project Manager
Clinical Trials Center Cologne
Gleueler Strasse 269, 50935 Cologne, Germany
Telefon +49 221 - 478-88136
Telefax +49 221 - 478-7983
Email meike.thurat@uni-koeln.de

Coordinating Study Center - Cologne
Dr. E. W. Kuhn - Trial Coordination
Dr. P. Krause - Trial Coordination
A. Plate - Study Nurse
Dept. of Cardiothoracic Surgery, Heart Center
Kerpener Str. 62, 50937 Cologne
Telefon +49 221 478 88375
Telefax +49 221 478 98432
Email start-cabg@uk-koeln.de

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