Overview

Statin Recapture Therapy Before Coronary Artery Bypass Grafting

Status:
Completed

Trial end date:
2019-09-24

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Cologne

Collaborator:

German Federal Ministry of Education and Research

Treatments:

Atorvastatin
Atorvastatin Calcium
Fluvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pravastatin
Simvastatin

Criteria

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

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 upper limit of normal (ULN), dialysis, kidney transplant)
or hepatic dysfunction (AST/ALT>2x ULN, liver transplant or neoplasm)

6. Inability of oral drug intake