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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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.

Eligibility

Primary outcome measure(s)

• Number and rate of patients with confirmed recurrent VTE and VTE-related death (efficacy). — From date of enrollment until the date of first documented event assessed up to 12 months
  The occurrence of proximal deep vein thrombosis with or without pulmonary embolism (new or recurrent episode) wil be recorded in all patients
• Number and rate of major Bleeding events (defined according to International Society on Thrombosis and Haemostasis guidelines (safety) — From date of enrollment until the date of first documented event assessed up to 12 months
  Fatal bleeding; intracranial; intraspinal; intraocular; pericardial; intra-articular; intramuscular with compartment syndrome; retroperitoneal,; acute clinically overt bleeding will be recorded in all patients

Trial sites (1)

Other trials for the same condition