Sulodexide, VESSEL®, for the Prevention of Recurrent Venous Thromboembolism (The Jason Study)
Recruiting
Phase 3
Interventional Study
Venous Thromboembolism
Anticoagulant
Elderly
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 75 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 1,455 (estimated)
- Sponsor
- Arianna Anticoagulazione Foundation · Other
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About This Trial
The study aims at optimizing extended management of elderly patients (\> 75 years) with at least one of the known bleeding risk factor, who suffered from first episode of venous thromboembolism of the lower extremity (proximal deep vein thrombosis with or without pulmonary embolism) (VTE). Patients were randomized to receive three different treatment: Sulodexide 250 mg BIS in die; Sulodexide 500 B…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Patients with a first event of proximal lower extremity DVT and / or PE, idiopathic or associated with weak or removed risk factors.
2. Patients aged ≥75 years at the time of enrolment
3. Patients with at least one of the known risk factors of bleeding (APPENDIX 1):
1. Hy…
Contacts