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

NCT07118449 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2025-08-12

No results posted yet for this study

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).

Conditions

  • Coronary Artery Disease (CAD)

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.

Sponsors & Collaborators

  • XyloCor Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-27
Primary Completion
2026-12-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07118449 on ClinicalTrials.gov