Prevention of recurrence after a first episode of Venous Thromboembolism (VTE)
Conditions
Brief summary
Primary efficacy endpoint: -cumulative result of: new episodes of venous thromboembolism (proximal DVT and / or PE), overall mortality due to VTE, Primary safety endpoint: - incidence of major bleeding (MB), International Society on Thrombosis and Haemostasis [ISTH] criteria
Detailed description
Secondary efficacy endpoint: Superficial venin thrombosis; Isolated distal deep vein thrombosis;, Cardiovascular events that involved hospitalization; Death from cardiovascular events (myocardial infarction, ischemic stroke)., Secondary safety endpoint: Cumulative incidence of MB and non-major but clinically relevant haemorrhages [NMCRB]
Interventions
DRUGThe placebo product consists of a soft capsule similar to the ones containing the active substance
DRUGVESSEL® 250 ULS capsule molli
Sponsors
Fondazione Arianna Anticoagulazione
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy endpoint: Superficial venin thrombosis; Isolated distal deep vein thrombosis;, Cardiovascular events that involved hospitalization; Death from cardiovascular events (myocardial infarction, ischemic stroke)., Secondary safety endpoint: Cumulative incidence of MB and non-major but clinically relevant haemorrhages [NMCRB] | — |
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy endpoint: -cumulative result of: new episodes of venous thromboembolism (proximal DVT and / or PE), overall mortality due to VTE, Primary safety endpoint: - incidence of major bleeding (MB), International Society on Thrombosis and Haemostasis [ISTH] criteria | — |
Countries
Italy
Outcome results
None listed