Trial document




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  DRKS00000753

Trial Description

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Title

Statin Recapture Therapy before Coronary Artery Bypass Grafting.

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Trial Acronym

StaRT-CABG Trial

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URL of the Trial

http://www.start-cabg.de

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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’ co-morbidities
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.

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Organizational Data

  •   DRKS00000753
  •   2012/10/17
  •   [---]*
  •   yes
  •   Approved
  •   12-207, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  •   2011-001795-19 
  •   4038404 
  •   01KG1103  (BMBF, Förderkennzeichen )
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Health Condition or Problem studied

  •   I25.1 -  Atherosclerotic heart disease
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Interventions/Observational Groups

  •   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)
  •   Placebo given orally 12 hrs and 2 hrs before CABG
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, assessor, data analyst
  •   Placebo
  •   Treatment
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

Primary efficacy endpoint:
Major adverse cardiocerebral events (MACCE) within 30 days after CABG.
Composite endpoint consisting of:
(1) all-cause mortality, (2) non-fatal myocardial infarction (MI) and (3) non-fatal
cerebrovascular event (stroke or TIA)

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Secondary Outcome

1. Major adverse cardiac events: cardiac mortality and non-fatal MI within 30
days
2. New-onset atrial fibrillation
3. Postoperative enzymatic myocardial injury (troponin T, CK-MB)
4. Length of stay on intensive care unit (ICU) and hospital
5. Repeat coronary revascularisation
6. All-cause mortality at 12 months

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/11/07
  •   2630
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Key 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

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Exclusion Criteria

Key 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 ULN, dialysis, kidney transplant) or hepatic
dysfunction (AST/ALT>2x ULN, liver transplant or neoplasm)
6. Inability of oral drug intake

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Addresses

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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn (BMBF, Förderkennzeichen 01KG1103)
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  • [---]*
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