Sulodexide, VESSEL®, for the Prevention of Recurrent Venous Thromboembolism (The Jason Study) (NCT04257487) | Clinical Trial Compass
RecruitingPhase 3
Sulodexide, VESSEL®, for the Prevention of Recurrent Venous Thromboembolism (The Jason Study)
Italy1,455 participantsStarted 2020-12-21
Plain-language summary
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 BID in die or indistinguishable placebo to verify the efficacy and safety of extended treatment for 12 months with Sulodexide (Vessel®) in the secondary prevention of Deep Vein Thrombosis / Pulmonary Embolism (DVT/PE) recurrence.
Who can participate
Age range75 Years
SexALL
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Inclusion criteria
✓. Patients with a first event of proximal lower extremity DVT and / or PE, idiopathic or associated with weak or removed risk factors.
✓. Patients aged ≥75 years at the time of enrolment
✓. Patients with at least one of the known risk factors of bleeding (APPENDIX 1):
✓. Hypertension
✓. Renal failure
✓. Thrombocytopenia
✓. Diabetes
✓. Antiplatelet therapy (ASA maximum 140 mg/die)
Exclusion criteria
✕. Patients aged \<75 years at the time of the recruitment visit.
✕. "Provoked" index event, which occurred:
✕. Index event represented by severe PE, with life threatening risk or treated with thrombolytic therapy.
What they're measuring
1
Number and rate of patients with confirmed recurrent VTE and VTE-related death (efficacy).
Timeframe: From date of enrollment until the date of first documented event assessed up to 12 months
2
Number and rate of major Bleeding events (defined according to International Society on Thrombosis and Haemostasis guidelines (safety)
Timeframe: From date of enrollment until the date of first documented event assessed up to 12 months