Clinical trial NCT01715714: Statin Recapture Therapy Before Coronary Artery Bypass Grafting
Official title: Statin Recapture Therapy Before Coronary Artery Bypass Grafting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Statins
Coronary Artery Bypass Grafting
Cardiac Surgery
Lead sponsor: University of Cologne
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2012-10-29
Enrollment: 2630
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Major adverse cardiocerebral events (MACCE) within 30 days after CABG.
timeFrame: 30 days after Surgery
Secondary outcomes:
measure: Major adverse cardiac events
timeFrame: 30 days after Surgery
measure: Length of stay
timeFrame: within the first 15 days after surgery (plus or minus 5 days)
measure: Repeat coronary revascularisation
timeFrame: 30 days after surgery
measure: Mortality at 12 months
timeFrame: 12 months after surgery
measure: Wound Infections
timeFrame: 30 days after surgery
measure: Atrial fibrillation
timeFrame: within the first 15 days after surgery (plus or minus 5 days)
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Heart Center Freiburg-Bad Krozingen
state: Baden-Württemberg
city: Bad Neustadt An Der Saale
country: Germany
facility: Heart Center Bad Neustadt
state: Bayern
city: Aachen
country: Germany
facility: University of Aachen
state: NRW
city: Bad Oeynhausen
country: Germany
facility: Heart Center Bad Oeynhausen
state: NRW
city: Bochum
country: Germany
facility: University of Bochum
state: NRW
city: Bonn
country: Germany
facility: University of Bonn
state: NRW
city: Cologne
country: Germany
facility: University of Cologne
state: NRW
city: Essen
country: Germany
facility: University of Essen
state: NRW
city: Muenster
country: Germany
facility: University of Muenster
state: NRW
city: Wuppertal
country: Germany
facility: Helios Heart Center Wuppertal
state: NRW
Study officials:
affiliation: University of Cologne
name: Oliver J Liakopoulos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.