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NOT YET RECRUITING
NCT07118449
PHASE2

Epicardial Delivery of XC001 Gene Therapy to Promote Angiogenesis in CAD Patients Undergoing Treatment With CABG

Sponsor: XyloCor Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

This is a 26-week (with a 26-week extension) multicenter, randomized, double-blind, placebo-controlled Phase 2 study of XC001 versus placebo. Approximately 116 participants who have CAD and have been referred for revascularization by CABG and who have, according to assessment by stress imaging multiple myocardial segments that are substantially ischemic, and that are unlikely to be fully revascularized during CABG for technical reasons, including diffuse atherosclerosis, lack of conduits, or insufficient target vessels. Patients will be randomized in a 1:1 to XC001 or placebo injections during the final stages of the CABG procedure. Patients will have a baseline CMR at day 4-6 post CABG and additional assessments in the primary study period will be performed on Day 14, and Weeks 4, 12, and 26, (and during the extension period at 52 weeks).

Official 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

116

Start Date

2025-08-27

Completion Date

2027-06-30

Last Updated

2025-08-12

Healthy Volunteers

No

Interventions

DRUG

XC001

22 injections will be administered at the end of the CABG procedure as a one time treatment.

DRUG

A195/placebo

22 injections of A195/placebo will be administered at the end of the CABG procedure.

Locations (1)

Christ Hospital

Cincinnati, Ohio, United States