Statin Recapture Therapy Before Coronary Artery Bypass Grafting

Coronary Artery Disease Clinical Trial

— StaRT-CABG  

Official title:

Statin Recapture Therapy Before Coronary Artery Bypass Grafting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01715714
• Other study ID #: Uni-Koeln-1341
• Secondary ID: 2011-001795-19DR
• Status: Completed
• Phase: Phase 4
• Start date: November 7, 2012
• Est. completion date: September 27, 2020

Study information

• Verified date: July 2022
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2630
• Est. completion date: September 27, 2020
• Est. primary completion date: April 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Statin Recapture Therapy
Given 12h and 2h before CABG
• Placebo
Given 12h and 2h before CABG.

Locations

Country	Name	City	State
Germany	University of Aachen	Aachen	NRW
Germany	Heart Center Bad Neustadt	Bad Neustadt An Der Saale	Bayern
Germany	Heart Center Bad Oeynhausen	Bad Oeynhausen	NRW
Germany	University of Bochum	Bochum	NRW
Germany	University of Bonn	Bonn	NRW
Germany	University of Cologne	Cologne	NRW
Germany	University of Essen	Essen	NRW
Germany	Heart Center Freiburg-Bad Krozingen	Freiburg	Baden-Württemberg
Germany	University of Muenster	Muenster	NRW
Germany	Helios Heart Center Wuppertal	Wuppertal	NRW

Sponsors (2)

Lead Sponsor	Collaborator
University of Cologne	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Major adverse cardiac events	Composite outcome consisting cardiac mortality and non-fatal MI within 30 days after surgery.	30 days after Surgery
Secondary	Length of stay	Length of stay on intensive care unit (ICU) and hospital	within the first 15 days after surgery (plus or minus 5 days)
Secondary	Repeat coronary revascularisation	Repeat coronary revascularisation (PCI or CABG)	30 days after surgery
Secondary	Mortality at 12 months	All-cause mortality at 12 months	12 months after surgery
Secondary	Wound Infections	Surgical site wound infections.	30 days after surgery
Secondary	Atrial fibrillation	New-onset postoperative atrial fibrillation	within the first 15 days after surgery (plus or minus 5 days)

External Links

•   StaRT CABG Homepage