EXACT-CABG
Research type
Research Study
Full title
A 26-Week (with 26 Week Extension) Randomized, Multi-Center, Double-Blind Phase 2 Study to Evaluate the Efficacy and Safety of XC001 Gene Therapy as an Adjunct to Coronary Artery Bypass Graft Surgery for Patients with Symptomatic Coronary Artery Disease with Left Ventricular Dysfunction at Risk for Incomplete Revascularization
IRAS ID
1012066
Contact name
Deborah Finnerty
Contact email
Sponsor organisation
XyloCor Therapeutics, Inc.
Research summary
Approx. 35% to 43% of all coronary artery bypass graft (CABG) procedures result in incomplete revascularisation (diseased arteries supplying blood to the heart muscle not fully treated). XyloCor is developing XC001 for Coronary Artery Disease (CAD) at high risk for incomplete revascularisation via CABG. This is a 26-week (with a 26-week extension) multicentre, randomised, double-blind, placebo- controlled Phase 2 study. 116 participants will take part in the US, Poland, Germany, Hungary, Netherlands, Serbia and UK (4 NHS hospitals) who have CAD, referred for CABG and at risk of incomplete revascularisation. The study will evaluate the effects of XC001 versus placebo on residual ischemic burden (lack of blood to the heart resulting in insufficient oxygen) by Cardiac Magnetic Resonance (CMR) imaging. The study will also evaluate the safety and tolerability of XC001 versus placebo. After providing informed consent, participants will be screened up to 50 days prior to dosing. Screening assessments are reviewed by the Eligibility Review Committee (ERC) for consensus on suitability for the trial. Eligible participants are admitted to hospital for the CABG procedure and randomised to receive either XC001 or placebo (1:1 ratio). XC001 will be administered by epicardial injections during the CABG procedure. Participants will be monitored in hospital for approximately 5 days following the surgery. An Independent Data Monitoring Committee (IDMC) will monitor safety and a clinical endpoints committee (CEC) will adjudicate clinical events. All participants will undergo CMR imaging as outlined in the Schedule of Assessments. The baseline CMR will be performed between Day 4 and 6 post-CABG. Subsequent assessments be performed on Day 14, and Weeks 4, 12, and 26 (and the extension period at 52 weeks). The safety and tolerability will be monitored throughout. At the end of the follow-up period, participants will be invited to participate in a separate long-term follow-up study.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
25/SC/0387
Date of REC Opinion
5 Feb 2026
REC opinion
Further Information Favourable Opinion