Statin Recapture Therapy Before Coronary Artery Bypass Grafting (StaRT-CABG)

University of Cologne

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: Placebo; Drug: Statin Recapture Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01715714

Uni-Koeln-1341

2011-001795-19 (EudraCT Number)

DRKS00000753 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,630 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,630 participants in 2 patient groups, including a placebo group

Statin Recapture Therapy

Active Comparator group

Description:

Oral statin reload of patients at 12 and 2 hours before CABG using the maximal dose of the chronically prescribed statin\* on admission. (\*simvastatin 80 mg, atorvastatin 80 mg, fluvastatin 80 mg or pravastatin 40 mg)

Treatment:

Drug: Statin Recapture Therapy

Placebo

Placebo Comparator group

Description:

Placebo given orally 12 hrs and 2 hrs before CABG

Treatment:

Drug: Placebo