NCT01715714

Statin Recapture Therapy Before Coronary Artery Bypass Grafting

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,630 (actual)
• Sponsor: University of Cologne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Statin Recapture Therapy	Given 12h and 2h before CABG
DRUG	Placebo	Given 12h and 2h before CABG.

Timeline

• Start date: 2012-11-07
• Primary completion: 2019-04-24
• Completion: 2020-09-27
• First posted: 2012-10-29
• Last updated: 2022-07-22

Locations

10 sites across 1 country: Germany