Sulodexide, VESSEL®, for the Prevention of Recurrent Venous Thromboembolism (The Jason Study) (NCT04257487) | Clinical Trial Compass
RecruitingPhase 3
Sulodexide, VESSEL®, for the Prevention of Recurrent Venous Thromboembolism (The Jason Study)
Italy1,455 participantsStarted 2020-12-21
Plain-language 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.
Who can participate
Age range
75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients with a first event of proximal lower extremity DVT and / or PE, idiopathic or associated with weak or removed risk factors.
. Patients aged ≥75 years at the time of enrolment
. Patients with at least one of the known risk factors of bleeding (APPENDIX 1):
. Hypertension
. Renal failure
. Thrombocytopenia
. Diabetes
. Antiplatelet therapy (ASA maximum 140 mg/die)
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number and rate of patients with confirmed recurrent VTE and VTE-related death (efficacy).
Timeframe: From date of enrollment until the date of first documented event assessed up to 12 months
2
Number and rate of major Bleeding events (defined according to International Society on Thrombosis and Haemostasis guidelines (safety)
Timeframe: From date of enrollment until the date of first documented event assessed up to 12 months