Statin Recapture Therapy Before Coronary Artery Bypass Grafting
StaRT-CABG
3 other identifiers
interventional
2,630
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 coronary-artery-disease
Started Nov 2012
Longer than P75 for phase_4 coronary-artery-disease
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2012
CompletedFirst Posted
Study publicly available on registry
October 29, 2012
CompletedStudy Start
First participant enrolled
November 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 24, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 27, 2020
CompletedJuly 22, 2022
July 1, 2022
6.5 years
October 18, 2012
July 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
30 days after Surgery
Secondary Outcomes (6)
Major adverse cardiac events
30 days after Surgery
Length of stay
within the first 15 days after surgery (plus or minus 5 days)
Repeat coronary revascularisation
30 days after surgery
Mortality at 12 months
12 months after surgery
Wound Infections
30 days after surgery
- +1 more secondary outcomes
Study Arms (2)
Statin Recapture Therapy
ACTIVE COMPARATOROral 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
PLACEBO COMPARATORPlacebo given orally 12 hrs and 2 hrs before CABG
Interventions
Given 12h and 2h before CABG
Eligibility Criteria
You may qualify if:
- Patients on chronic statin treatment (\>30 days) scheduled for isolated CABG, including on- or off-pump or repeat (redo's) revascularisation procedures
- Stable or unstable angina, including non ST-segment-elevation acute coronary syndrome (NSTE-ACS)
- Age ≥ 18 years
- Written informed consent
You may not qualify if:
- Any concomitant cardiovascular procedure to CABG (i.e. valve, aortic or carotid surgery)
- Acute ST-segment-elevation myocardial infarction (STEMI)
- NSTE-ACS with cardiogenic shock warranting emergent salvage surgery within 12 hrs from hospital admission
- History of atrial fibrillation or muscle disease (myopathy)
- Current renal (creatinine\>2x upper limit of normal (ULN), dialysis, kidney transplant) or hepatic dysfunction (AST/ALT\>2x ULN, liver transplant or neoplasm)
- Inability of oral drug intake
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Heart Center Freiburg-Bad Krozingen
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Heart Center Bad Neustadt
Bad Neustadt an der Saale, Bavaria, 97616, Germany
University of Aachen
Aachen, North Rhine-Westphalia, 52074, Germany
Heart Center Bad Oeynhausen
Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany
University of Bochum
Bochum, North Rhine-Westphalia, Germany
University of Bonn
Bonn, North Rhine-Westphalia, 53127, Germany
University of Cologne
Cologne, North Rhine-Westphalia, 50924, Germany
University of Essen
Essen, North Rhine-Westphalia, 45122, Germany
University of Muenster
Münster, North Rhine-Westphalia, 48149, Germany
Helios Heart Center Wuppertal
Wuppertal, North Rhine-Westphalia, 42117, Germany
Related Publications (1)
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.
PMID: 26093863DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oliver J Liakopoulos, MD, PhD
University of Cologne
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 18, 2012
First Posted
October 29, 2012
Study Start
November 7, 2012
Primary Completion
April 24, 2019
Study Completion
September 27, 2020
Last Updated
July 22, 2022
Record last verified: 2022-07