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Sulodexide, VESSEL®, for the Prevention of Recurrent Venous Thromboembolism (The Jason Study)
Sponsor: Arianna Anticoagulazione Foundation
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.
Official title: Sulodexide (VESSEL®) for the Prevention of Recurrent Venous Thromboembolism in Elderly Patients After a First Episode of Venous Thrombembolism
Key Details
Gender
All
Age Range
75 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1455
Start Date
2020-12-21
Completion Date
2027-01-02
Last Updated
2024-07-31
Healthy Volunteers
No
Interventions
Sulodexide
2 soft capsules of Vessel® 250 LSU BID for 12 months
Sulodexide and placebo
1 soft capsule of Vessel® 250 LSU and 1 soft capsule of placebo BID for 12 months
Placebo
Sugar pill manufactured to mimic sulodexide 250 LSU
Locations (1)
Corrado Lodigiani
Rozzano, Italy