NCT04257487 Sulodexide, VESSEL®, for the Prevention of Recurrent Venous Thromboembolism (The Jason Study)
| NCT ID | NCT04257487 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Arianna Anticoagulazione Foundation |
| Condition | Venous Thromboembolism |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,455 participants |
| Start Date | 2020-12-21 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,455 participants in total. It began in 2020-12-21 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Patients with a first event of proximal lower extremity DVT and / or PE, idiopathic or associated with weak or removed risk factors. 2. Patients aged ≥75 years at the time of enrolment 3. Patients with at least one of the known risk factors of bleeding (APPENDIX 1): 1. Hypertension 2. Renal failure 3. Thrombocytopenia 4. Diabetes 5. Antiplatelet therapy (ASA maximum 140 mg/die) 6. Frequent falls (\>2 /years) 7. Nonsteroidal anti-inflammatory drug 8. Liver failure 9. Previous Stroke 10. Anemia 11. Poor anticoagulant control 12. Alcohol abuse 4. Patients of both sexes. 5. Patients who at the time of enrolment have already undergone a period of anticoagulant therapy (AT, with any medication) of at least 3 months and the therapy has not been suspended for more than 30 days. 6. Patients with no other AT indications. 7. Patients capable and able to provide informed consent Exclusion Criteria: 1. Patients aged \<75 years at the time of the recruitment visit. 2. "Provoked" index event, which occurred: * Within 3 months of surgery or major trauma, * Bed Rest \> 4 days, * Cast / immobility within 3 months. 3. Index event represented by severe PE, with life threatening risk or treated with thrombolytic therapy. 4. Index event represented by isolated distal DVT or superficial venous thrombosis. 5. Thrombotic event in sites other than the deep proximal veins of the lower limbs. 6. Anticoagulant therapy for less than 3 months at the time of enrolment. 7. Discontinuation of anticoagulant therapy for over thirty days at the time of enrolment 8. Recurrent episodes of DVT ± PE
Contact & Investigator
Corrado Lodigiani, MD,PhD
STUDY CHAIR
IRCCS Humanitas, Rozzano (Milano)
Frequently Asked Questions
Who can join the NCT04257487 clinical trial?
This trial is open to participants of all sexes, aged 75 Years or older, studying Venous Thromboembolism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04257487 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,455 participants.
Is NCT04257487 currently recruiting?
Yes, NCT04257487 is actively recruiting participants. Contact the research team at c.legnani@fondazionearianna.org for enrollment information.
Where is the NCT04257487 trial being conducted?
This trial is being conducted at Rozzano, Italy.
Who is sponsoring the NCT04257487 clinical trial?
NCT04257487 is sponsored by Arianna Anticoagulazione Foundation. The principal investigator is Corrado Lodigiani, MD,PhD at IRCCS Humanitas, Rozzano (Milano). The trial plans to enroll 1,455 participants.