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NCT04257487: Jason

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

Recruiting now Phase 3 Last updated 31 July 2024
What this trial tests

Phase 3 trial testing Sulodexide in Venous Thromboembolism in 1,455 participants. Currently enrolling.

Timeline
21 December 2020
Primary endpoint
31 December 2025
2 January 2027

Quick facts

Lead sponsorArianna Anticoagulazione Foundation
PhasePhase 3
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeprevention
Enrollment1,455
Start date21 December 2020
Primary completion31 December 2025
Estimated completion2 January 2027
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Arianna Anticoagulazione Foundation

Who can join

75 and older, any sex, with Venous Thromboembolism or Anticoagulant. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Heterologous production of chondroitin.
    Couto MR, Rodrigues JL, Rodrigues LR. · · 2022 · cited 8× · PMID 35242620 · DOI 10.1016/j.btre.2022.e00710
  2. 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.
    Palareti G, Legnani C, Antonucci E, Zorzi S, et al · · 2021 · cited 4× · PMID 32451933 · DOI 10.1007/s11739-020-02381-5

Verify or expand the search:

Other trials of Sulodexide

Trials testing the same drug.

Other recruiting trials for Venous Thromboembolism

Currently open trials in the same condition.

Other Arianna Anticoagulazione Foundation trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04257487.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing