chronically occluded coronary artery
Conditions
Brief summary
Net adverse clinical events: time-to-composite endpoint of bleeding events (BARC2 to BARC 5) and/or ischemic events (all cause death, stroke, stent thrombosis, myocardial infarction, repeat revascularization, rehospitalisation for angina) during follow-up (12 months), or time to last follow-up in case of no net adverse clinical event
Detailed description
Time-to-bleeding event defined according to BARC classification (BARC 2 to BARC 5) over 12 months follow up, taking into account the competing risk of death from non-haemorrhagic cause, or time to last follow-up in case of no bleeding event, Time-to-all cause death over 12 months follow-up, or time to last follow-up in case of no death, Major adverse ischemic clinical events (MACE): time-to-composite endpoint of ischemic stroke, cardiovascular death, stent thrombosis, repeat revascularization, rehospitalisation for angina over 12 months follow-up, taking into account the competing risk of death from non-cardiovascular cause, or time to last follow-up in case of no MACE, Compliance to drug regimen at 1-, 6- and 12-months follow-up, Total costs in each treatment group over the one-year study period, Total quality-adjusted life years in each treatment group over the one-year study period, Long-term cost-utility ratio (expressed in terms of additional costs per quality adjusted life year gained)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Net adverse clinical events: time-to-composite endpoint of bleeding events (BARC2 to BARC 5) and/or ischemic events (all cause death, stroke, stent thrombosis, myocardial infarction, repeat revascularization, rehospitalisation for angina) during follow-up (12 months), or time to last follow-up in case of no net adverse clinical event | — |
Secondary
| Measure | Time frame |
|---|---|
| Time-to-bleeding event defined according to BARC classification (BARC 2 to BARC 5) over 12 months follow up, taking into account the competing risk of death from non-haemorrhagic cause, or time to last follow-up in case of no bleeding event, Time-to-all cause death over 12 months follow-up, or time to last follow-up in case of no death, Major adverse ischemic clinical events (MACE): time-to-composite endpoint of ischemic stroke, cardiovascular death, stent thrombosis, repeat revascularization, rehospitalisation for angina over 12 months follow-up, taking into account the competing risk of death from non-cardiovascular cause, or time to last follow-up in case of no MACE, Compliance to drug regimen at 1-, 6- and 12-months follow-up, Total costs in each treatment group over the one-year study period, Total quality-adjusted life years in each treatment group over the one-year study period, Long-term cost-utility ratio (expressed in terms of additional costs per quality adjusted life year g | — |
Countries
France