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

This study is currently recruiting participants.
Verified October 2012 by University of Cologne
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
PD Dr. Oliver J. Liakopoulos, University of Cologne
ClinicalTrials.gov Identifier:
NCT01715714
First received: October 18, 2012
Last updated: October 26, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Drug: Statin Recapture Therapy
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Statin Recapture Therapy Before Coronary Artery Bypass Grafting

Resource links provided by NLM:


Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • Major adverse cardiocerebral events (MACCE) within 30 days after CABG. [ Time Frame: 30 days after Surgery ] [ Designated as safety issue: No ]
    Composite endpoint consisting of (1) all-cause mortality, (2) non-fatal myocardial infarction (MI) and (3) non-fatal cerebrovascular event (stroke or TIA).


Secondary Outcome Measures:
  • Major adverse cardiac events [ Time Frame: 30 days after Surgery ] [ Designated as safety issue: No ]
    Composite outcome consisting cardiac mortality and non-fatal MI within 30 days after surgery.

  • Length of stay [ Time Frame: within the first 15 days after surgery (plus or minus 5 days) ] [ Designated as safety issue: No ]
    Length of stay on intensive care unit (ICU) and hospital

  • Repeat coronary revascularisation [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    Repeat coronary revascularisation (PCI or CABG)

  • Mortality at 12 months [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    All-cause mortality at 12 months

  • Wound Infections [ Time Frame: 30 days after surgery ] [ Designated as safety issue: Yes ]
    Surgical site wound infections.

  • Atrial fibrillation [ Time Frame: within the first 15 days after surgery (plus or minus 5 days) ] [ Designated as safety issue: No ]
    New-onset postoperative atrial fibrillation


Estimated Enrollment: 2630
Study Start Date: October 2012
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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)
Drug: Statin Recapture Therapy
Given 12h and 2h before CABG
Other Names:
  • Simvastatin 80 mg
  • Atorvastatin 80 mg
  • Pravastatin 40 mg
  • Fluvastatin 80 mg
Placebo Comparator: Placebo
Placebo given orally 12 hrs and 2 hrs before CABG
Drug: Placebo
Given 12h and 2h before CABG.
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01715714

Contacts
Contact: Oliver J. Liakopoulos, MD, PhD +49 221 478 ext 32450 oliver.liakopoulos@uk-koeln.de
Contact: Petra Krause, MD +49 221 478 ext 88375 petra.krause@uk-koeln.de

Locations
Germany
University of Aachen Recruiting
Aachen, NRW, Germany, 52074
Contact: Rüdiger Autschbach, MD, Prof.         
Sub-Investigator: Andreas Goetzenich, MD         
Principal Investigator: Rüdiger Autschbach, MD, Prof.         
Heart Center Bad Oeynhausen Recruiting
Bad Oeynhausen, NRW, Germany, 32545
Contact: Jan Gummmert, MD, Prof.         
Principal Investigator: Jochen Börgermann, MD, PhD         
Principal Investigator: Jan Gummert, MD, Prof.         
University of Bochum Recruiting
Bochum, NRW, Germany
Contact: Justus Strauch, MD, Prof.         
Principal Investigator: Mügge, MD, Prof.         
Sub-Investigator: Peter Haldenwang, MD         
University of Bonn Recruiting
Bonn, NRW, Germany, 53127
Contact: Wolfgang Schiller, MD         
Principal Investigator: Wolfgang Schiller, MD         
Principal Investigator: Armin Welz, MD, Prof.         
University of Cologne Recruiting
Cologne, NRW, Germany, 50924
Contact: Oliver J Liakopoulos, MD, PhD    +49 221 478 ext 32450    oliver.liakopoulos@uk-koeln.de   
Principal Investigator: Oliver J Liakopoulos, MD, PhD         
Principal Investigator: Thorsten Wahlers, MD, Prof.         
University of Essen Recruiting
Essen, NRW, Germany, 45122
Contact: Matthias Thielmann, MD, PhD         
Principal Investigator: Matthias Thielmann, MD, PhD         
Principal Investigator: Heinz Jakob, MD, Prof.         
Sub-Investigator: Daniel Wendt, MD         
University of Muenster Recruiting
Muenster, NRW, Germany, 48149
Contact: Henryk Welp, MD         
Principal Investigator: Henryk Welp, MD         
Principal Investigator: Sven Martens, MD, Prof.         
Helios Heart Center Wuppertal Recruiting
Wuppertal, NRW, Germany, 42117
Contact: Herbert Vetter, MD, Prof.         
Principal Investigator: Herbert Vetter, MD, Prof.         
Sub-Investigator: Veaceslav Ciobanu, MD         
Sponsors and Collaborators
University of Cologne
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Oliver J Liakopoulos, MD, PhD University of Cologne
  More Information

Additional Information:
No publications provided

Responsible Party: PD Dr. Oliver J. Liakopoulos, Principal Investigator, University of Cologne
ClinicalTrials.gov Identifier: NCT01715714     History of Changes
Other Study ID Numbers: Uni-Koeln-1341, 2011-001795-19, DRKS00000753
Study First Received: October 18, 2012
Last Updated: October 26, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Cologne:
Coronary Artery Disease
Statins
Coronary Artery Bypass Grafting
Cardiac Surgery

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Simvastatin
Atorvastatin
Fluvastatin
Pravastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014