Epicardial Delivery of XC001 Gene Therapy to Promote Angiogenesis in CAD Patients Undergoing Trea… (NCT07118449) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Epicardial Delivery of XC001 Gene Therapy to Promote Angiogenesis in CAD Patients Undergoing Treatment With CABG
United States116 participantsStarted 2025-08-27
Plain-language 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).
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to screening. In addition, at least 2 high follicle stimulating hormone (FSH) measurements in the postmenopausal range must be used to confirm a postmenopausal state in women with less than 12 months of amenorrhea and not using hormonal replacement surgery; OR
. Surgically sterile (i.e., hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) at least 1 month prior to Screening 6. Female participants agree to not donate oocytes and male participants must agree not to donate sperm for 6 months following administration of investigational protocol.
Exclusion criteria
. ST elevation myocardial infarction (STEMI) or cerebral vascular accident within the past 60 days prior to the Screening visit;
. Sustained, current systolic blood pressure (BP) less than 90 mmHg or uncontrolled hypertension (systolic BP \> 180 mmHg, diastolic BP \> 100 mmHg) despite maximal medical treatment;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline (Day 4-6 CMR) in treated segment(s) comparing XC001 and placebo in CMR imaging parameters at Weeks 12 and 26 post-surgery.
. Current untreated malignant ventricular arrhythmia;
. Congestive heart failure (HF) within the last 60 days defined as New York Heart Association Functional Class IV;
. Current mitral or aortic valvular heart disease requiring mechanical intervention anticipated during the study period (including percutaneous intervention).