Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01715714
Recruitment Status : Completed
First Posted : October 29, 2012
Last Update Posted : February 26, 2020
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
PD Dr. Oliver J. Liakopoulos, University of Cologne

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Statin Recapture Therapy Drug: Placebo Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2630 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Statin Recapture Therapy Before Coronary Artery Bypass Grafting
Actual Study Start Date : October 2012
Actual Primary Completion Date : April 24, 2019
Actual Study Completion Date : September 24, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Major adverse cardiocerebral events (MACCE) within 30 days after CABG. [ Time Frame: 30 days after Surgery ]
    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 :
  1. Major adverse cardiac events [ Time Frame: 30 days after Surgery ]
    Composite outcome consisting cardiac mortality and non-fatal MI within 30 days after surgery.

  2. Length of stay [ Time Frame: within the first 15 days after surgery (plus or minus 5 days) ]
    Length of stay on intensive care unit (ICU) and hospital

  3. Repeat coronary revascularisation [ Time Frame: 30 days after surgery ]
    Repeat coronary revascularisation (PCI or CABG)

  4. Mortality at 12 months [ Time Frame: 12 months after surgery ]
    All-cause mortality at 12 months

  5. Wound Infections [ Time Frame: 30 days after surgery ]
    Surgical site wound infections.

  6. Atrial fibrillation [ Time Frame: within the first 15 days after surgery (plus or minus 5 days) ]
    New-onset postoperative atrial fibrillation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01715714


Locations
Layout table for location information
Germany
Heart Center Freiburg-Bad Krozingen
Freiburg, Baden-Württemberg, Germany, 79106
Heart Center Bad Neustadt
Bad Neustadt An Der Saale, Bayern, Germany, 97616
University of Aachen
Aachen, NRW, Germany, 52074
Heart Center Bad Oeynhausen
Bad Oeynhausen, NRW, Germany, 32545
University of Bochum
Bochum, NRW, Germany
University of Bonn
Bonn, NRW, Germany, 53127
University of Cologne
Cologne, NRW, Germany, 50924
University of Essen
Essen, NRW, Germany, 45122
University of Muenster
Muenster, NRW, Germany, 48149
Helios Heart Center Wuppertal
Wuppertal, NRW, Germany, 42117
Sponsors and Collaborators
University of Cologne
German Federal Ministry of Education and Research
Investigators
Layout table for investigator information
Principal Investigator: Oliver J Liakopoulos, MD, PhD University of Cologne
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: PD Dr. Oliver J. Liakopoulos, Principal Investigator, University of Cologne
ClinicalTrials.gov Identifier: NCT01715714    
Other Study ID Numbers: Uni-Koeln-1341
2011-001795-19 ( EudraCT Number )
DRKS00000753 ( Registry Identifier: German Clinical Trials Register (DRKS) )
First Posted: October 29, 2012    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Keywords provided by PD Dr. Oliver J. Liakopoulos, University of Cologne:
Coronary Artery Disease
Statins
Coronary Artery Bypass Grafting
Cardiac Surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Atorvastatin
Simvastatin
Pravastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors