Aortic bioprothesis implanted patient for valvular heart disease
Conditions
Brief summary
The primary endpoint is a composite efficacy endpoint including death, myocardial infarction, stroke, systemic embolism, deep vein thrombosis, or pulmonary embolism and valve thrombosis. The primary endpoint will be evaluated at the end of the treatment (105±15 days after inclusion and randomization).
Detailed description
Bleeding (primary safety endpoint) : ISTH major bleeding, Bleeding with ISTH bleeding scale : o ISTH major bleeding o ISTH non-major clinically relevant bleeding, Bleeding with the TIMI bleeding scale : o TIMI major bleeding o TIMI minor bleeding, Bleeding with the BARC definition (BARC 3 to 5), Composite efficacy endpoints including: All-cause death, Myocardial infarction (Fourth Universal Definition of Myocardial Infarction), Stroke, Systemic embolism, Deep vein thrombosis, Pulmonary embolism, Valve thrombosis, All-cause death, Aortic valve thrombosis (adapted from VARC-3 definition), Mean aortic gradient (mmHg) and peak velocity (m/s)
Interventions
DRUGACETYLSALICYLIC ACID
Sponsors
Assistance Publique Hopitaux De Paris
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is a composite efficacy endpoint including death, myocardial infarction, stroke, systemic embolism, deep vein thrombosis, or pulmonary embolism and valve thrombosis. The primary endpoint will be evaluated at the end of the treatment (105±15 days after inclusion and randomization). | — |
Secondary
| Measure | Time frame |
|---|---|
| Bleeding (primary safety endpoint) : ISTH major bleeding, Bleeding with ISTH bleeding scale : o ISTH major bleeding o ISTH non-major clinically relevant bleeding, Bleeding with the TIMI bleeding scale : o TIMI major bleeding o TIMI minor bleeding, Bleeding with the BARC definition (BARC 3 to 5), Composite efficacy endpoints including: All-cause death, Myocardial infarction (Fourth Universal Definition of Myocardial Infarction), Stroke, Systemic embolism, Deep vein thrombosis, Pulmonary embolism, Valve thrombosis, All-cause death, Aortic valve thrombosis (adapted from VARC-3 definition), Mean aortic gradient (mmHg) and peak velocity (m/s) | — |
Countries
France
Outcome results
None listed