Chronic angina and left ventricular dysfunction due to coronary artery disease that is considered high risk for incomplete revascularization via coronary artery bypass grafting
Conditions
Brief summary
Change from Baseline (post-CABG at Day 4-6) in treated segment(s) comparing XC001 and placebo in CMR imaging parameters at Weeks 12 and 26 post-surgery. The endpoint at the participant level is the proportion of qualifying segments that improve at 12 and/or 26 weeks as determined by myocardial ischemic burden (see details in the Protocol).
Detailed description
Change from Baseline (post-CABG at Day 4-6) in treated segment(s) comparing XC001 and placebo in CMR parameters at 12 and 26 weeks, as well as at 52 weeks (during the extension period) (unless stated otherwise). Baseline CMR is defined as CMR analysis at Day 4-6 post-CABG (see details regarding CMR parameters in the Protocol).
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline (post-CABG at Day 4-6) in treated segment(s) comparing XC001 and placebo in CMR imaging parameters at Weeks 12 and 26 post-surgery. The endpoint at the participant level is the proportion of qualifying segments that improve at 12 and/or 26 weeks as determined by myocardial ischemic burden (see details in the Protocol). | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline (post-CABG at Day 4-6) in treated segment(s) comparing XC001 and placebo in CMR parameters at 12 and 26 weeks, as well as at 52 weeks (during the extension period) (unless stated otherwise). Baseline CMR is defined as CMR analysis at Day 4-6 post-CABG (see details regarding CMR parameters in the Protocol). | — |
Countries
Germany, Hungary, Netherlands, Poland