intra-cardiac thrombus
Conditions
Brief summary
Net clinical benefit endpoint at 6 months: composite endpoint of all-cause death, myocardial infarction, stroke, acute peripheral emboli, acute pulmonary embolism, thrombus persistence and clinically relevant bleedings (Bleeding Academic Research Consortium 2, 3 and 5).
Detailed description
- Secondary efficacy endpoints: o All individual components of the composite ischemic endpoint at 6 and 12 months o Systemic embolism defined by the composite of stroke, embolic myocardial infarction, peripheral artery occlusion and acute pulmonary embolism at 6 and 12 months o Cardiovascular death at 6 and 12 months o Total thrombus regression at 6 and 12 months o Thrombus recurrence at different cardiac imaging follow-up, - Secondary safety endpoints: o Clinically relevant bleedings (international Bleeding Academic Research Consortium (BARC) types 2 to 5) at 6 and 12 months o Major bleedings (BARC 3 to 5) at 6 and 12 months
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Net clinical benefit endpoint at 6 months: composite endpoint of all-cause death, myocardial infarction, stroke, acute peripheral emboli, acute pulmonary embolism, thrombus persistence and clinically relevant bleedings (Bleeding Academic Research Consortium 2, 3 and 5). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Secondary efficacy endpoints: o All individual components of the composite ischemic endpoint at 6 and 12 months o Systemic embolism defined by the composite of stroke, embolic myocardial infarction, peripheral artery occlusion and acute pulmonary embolism at 6 and 12 months o Cardiovascular death at 6 and 12 months o Total thrombus regression at 6 and 12 months o Thrombus recurrence at different cardiac imaging follow-up, - Secondary safety endpoints: o Clinically relevant bleedings (international Bleeding Academic Research Consortium (BARC) types 2 to 5) at 6 and 12 months o Major bleedings (BARC 3 to 5) at 6 and 12 months | — |
Countries
France