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 range18 Years – 80 Years
SexALL
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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;
✕. Current untreated malignant ventricular arrhythmia;
✕. Congestive heart failure (HF) within the last 60 days defined as New York Heart Association Functional Class IV;
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 mitral or aortic valvular heart disease requiring mechanical intervention anticipated during the study period (including percutaneous intervention).