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

Sponsor
Arianna Anticoagulazione Foundation
Study ID
NCT04257487
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Anticoagulant
  • Elderly
  • Venous Thromboembolism

Eligibility Criteria

Sex
ALL
Age
75 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sulodexide — DRUG
    2 soft capsules of Vessel® 250 LSU BID for 12 months
  • Sulodexide and placebo — DRUG
    1 soft capsule of Vessel® 250 LSU and 1 soft capsule of placebo BID for 12 months
  • Placebo — DRUG
    Sugar pill manufactured to mimic sulodexide 250 LSU

Study Details

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.

Key Dates

First listed
Feb 6, 2020
Start date
Dec 21, 2020
Status verified
Jul 2024
Primary completion
Dec 31, 2025
Completion
Jan 2, 2027

Study Design

Enrollment
1,455 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Treatment A
    Sulodexide (Vessel) 2 capsules of 250 LSU BID, for 12 months
  • Active Comparator: Treatment B
    Sulodexide (Vessel) 1 capsule of 250 LSU and 1 indistinguishable placebo capsule BID., for 12 months
  • Placebo Comparator: Treatment C
    2 indistinguishable placebo capsules BID, for 12 months

Primary Outcome Measure

Number and rate of patients with confirmed recurrent VTE and VTE-related death (efficacy). [ Time Frame: From date of enrollment until the date of first documented event assessed up to 12 months ]

Central Contacts

Related Studies