Statin Recapture Therapy Before Coronary Artery Bypass Grafting

NCT ID: NCT01715714

Last Updated: 2022-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 2630 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-07
• Study Completion Date: 2020-09-27

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Statin Recapture Therapy

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)

Group Type: ACTIVE_COMPARATOR

Statin Recapture Therapy

Intervention Type: DRUG

Given 12h and 2h before CABG

Placebo

Placebo given orally 12 hrs and 2 hrs before CABG

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Given 12h and 2h before CABG.

Interventions

Statin Recapture Therapy

Given 12h and 2h before CABG

Intervention Type: DRUG

Placebo

Given 12h and 2h before CABG.

Intervention Type: DRUG

Other Intervention Names

Simvastatin 80 mg; Atorvastatin 80 mg; Pravastatin 40 mg; Fluvastatin 80 mg

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role: collaborator

University of Cologne

OTHER

Sponsor Role: lead

Responsible Party

PD Dr. Oliver J. Liakopoulos

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oliver J Liakopoulos, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cologne

Locations

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

Countries

Germany

References

Liakopoulos OJ, Kuhn EW, Hellmich M, Kuhr K, Krause P, Reuter H, Thurat M, Choi YH, Wahlers T; StaRT-CABG Investigators. Statin Recapture Therapy before Coronary Artery Bypass Grafting Trial: Rationale and study design of a multicenter, randomized, double-blinded controlled clinical trial. Am Heart J. 2015 Jul;170(1):46-54, 54.e1-2. doi: 10.1016/j.ahj.2015.04.015. Epub 2015 Apr 17.

Reference Type: DERIVED

PMID: 26093863 (View on PubMed)

Related Links

http://www.start-cabg.de

StaRT CABG Homepage

Other Identifiers

2011-001795-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DRKS00000753

Identifier Type: REGISTRY

Identifier Source: secondary_id

Uni-Koeln-1341

Identifier Type: -

Identifier Source: org_study_id