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NCT04257487: Jason
Sulodexide, VESSEL®, for the Prevention of Recurrent Venous Thromboembolism (The Jason Study)
Phase 3 trial testing Sulodexide in Venous Thromboembolism in 1,455 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | Arianna Anticoagulazione Foundation |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 1,455 |
| Start date | 21 December 2020 |
| Primary completion | 31 December 2025 |
| Estimated completion | 2 January 2027 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Sulodexide — full drug profile →
- Sulodexide and placebo — full drug profile →
- Placebo
Conditions studied
- Venous Thromboembolism — all drugs for Venous Thromboembolism →
- Anticoagulant — all drugs for Anticoagulant →
- Elderly — all drugs for Elderly →
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):
-
Heterologous production of chondroitin.
Couto MR, Rodrigues JL, Rodrigues LR. · · 2022 · cited 8× · PMID 35242620 · DOI 10.1016/j.btre.2022.e00710 -
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:
- PubMed search for NCT04257487
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT05252923 — Endothelial Protection in Convalescent COVID-19 Patients · Phase 4 · terminated
- NCT04483830 — Suloexide in the Treatment of Early Stages of COVID-19 · Phase 2, PHASE3 · completed
Other recruiting trials for Venous Thromboembolism
Currently open trials in the same condition.
- NCT07399977 — Using a Blood Test and Software Tool to Guide Treatment for Venous Thromboembolism · NA · recruiting
- NCT06861088 — The Effect of Kinisoquin™ on Thromboembolic Events in Patients With Metastatic or Locally Advanced Pancreatic Cancer · Phase 3 · recruiting
- NCT07140523 — A Study to Compare the Efficacy and Safety of SRSD107 and Enoxaparin in Adult Subjects Undergoing TKA · Phase 2 · recruiting
- NCT04211181 — CHIPs-VTE Study in Hospitalized Patients to Prevent Hospital-Acquired Venous Thromboembolism · NA · recruiting
- NCT06440694 — Colchicine to Quench the Inflammatory Response After Deep Vein Thrombosis (The Conquer-DVT Pilot Trial) · Phase 3 · recruiting
Other Arianna Anticoagulazione Foundation trials
Trials by the same sponsor.
- NCT04454554 — Prevalence of Pulmonary Embolism in Patients With Dyspnea on Exertion (PEDIS) · completed
- NCT03678506 — Apixaban for Extended Anticoagulation (APIDULCIS) · Phase 4 · terminated
- NCT03803579 — Baseline Concentration of Direct Oral Anticoagulant and Incidence of Adverse Event Measure And See (MAS) · completed
- NCT04646993 — WHITE Study: WHIch Decision After a First Venous ThromboEmbolism? · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04257487 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Arianna Anticoagulazione Foundation
- Last refreshed: 31 July 2024
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