Sulodexide, VESSEL®, for the Prevention of Recurrent Venous Thromboembolism (The Jason Study)
Sulodexide (VESSEL®) for the Prevention of Recurrent Venous Thromboembolism in Elderly Patients After a First Episode of Venous Thrombembolism
Arianna Anticoagulazione Foundation
1,455 participants
Dec 21, 2020
INTERVENTIONAL
Conditions
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
Inclusion Criteria19
- 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
Exclusion Criteria11
- 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
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Interventions
2 soft capsules of Vessel® 250 LSU BID for 12 months
1 soft capsule of Vessel® 250 LSU and 1 soft capsule of placebo BID for 12 months
Sugar pill manufactured to mimic sulodexide 250 LSU
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04257487