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RECRUITING
NCT04257487
PHASE3

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

Sponsor: Arianna Anticoagulazione Foundation

View on ClinicalTrials.gov

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

DRUG

Sulodexide

2 soft capsules of Vessel® 250 LSU BID for 12 months

DRUG

Sulodexide and placebo

1 soft capsule of Vessel® 250 LSU and 1 soft capsule of placebo BID for 12 months

DRUG

Placebo

Sugar pill manufactured to mimic sulodexide 250 LSU

Locations (1)

Corrado Lodigiani

Rozzano, Italy