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Prevention study for Venous Thromboembolism
Official title Sulodexide, VESSEL®, for the Prevention of Recurrent Venous Thromboembolism (The Jason Study)
ClinicalTrials.gov ID: NCT04257487
What this study is testing
What is Sulodexide?
Sulodexide is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for venous thromboembolism.
Also referred to as VESSEL®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 75 and older
You may be able to join if
- 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
You likely can't join if
- Patients aged \<75 years at the time of the recruitment visit.
- "Provoked" index event, which occurred:
- Within 3 months of surgery or major trauma,
- Bed Rest \> 4 days,
- Cast / immobility within 3 months.
- Index event represented by severe PE, with life threatening risk or treated with thrombolytic therapy.
See the full eligibility 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)
- Frequent falls (\>2 /years)
- Nonsteroidal anti-inflammatory drug
- Liver failure
- Previous Stroke
- Anemia
- Poor anticoagulant control
- Alcohol abuse
- Patients of both sexes.
- 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.
- Patients with no other AT indications.
- Patients capable and able to provide informed consent
- Patients aged \<75 years at the time of the recruitment visit.
- "Provoked" index event, which occurred:
- Within 3 months of surgery or major trauma,
- Bed Rest \> 4 days,
- Cast / immobility within 3 months.
- Index event represented by severe PE, with life threatening risk or treated with thrombolytic therapy.
- Index event represented by isolated distal DVT or superficial venous thrombosis.
- Thrombotic event in sites other than the deep proximal veins of the lower limbs.
- Anticoagulant therapy for less than 3 months at the time of enrolment.
- Discontinuation of anticoagulant therapy for over thirty days at the time of enrolment
- Recurrent episodes of DVT ± PE
The study team makes the final eligibility decision.
Where it's taking place
- Rozzano, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 75 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rozzano, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.