Sulodexide, VESSEL®, for the Prevention of Recurrent Venous Thromboembolism (The Jason Study)

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.

Timeline

Start

2020-12-21

Primary completion

2025-12-31

Completion

2027-01-02

Publications

• Palareti G, Legnani C, Antonucci E, Zorzi S, Bignamini AA, Lodigiani C, Tosetto A, Bertu L, Pengo V, Testa S, Ageno W, Prisco D, Prandoni P, Poli D. Design and rationale of a randomized, placebo-controlled trial on the efficacy and safety of sulodexide for extended treatment in elderly patients after a first venous thromboembolism. Intern Emerg Med. 2021 Mar;16(2):359-368. doi: 10.1007/s11739-020-02381-5. Epub 2020 May 25.

Drugs

Indications