Sulodexide, VESSEL®, for the Prevention of Recurrent Venous Thromboembolism (The Jason Study) (Jason)

  • End date
    Dec 2, 2023
  • participants needed
  • sponsor
    Arianna Anticoagulazione Foundation
Updated on 4 October 2022
anticoagulant therapy
secondary prevention
venous thromboembolism
deep vein thrombosis
pulmonary embolism


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.


This prospective cohort study aims to assess the efficacy and safety of the extended treatment with Sulodexide (Vessel®) in the secondary prevention of DVT / PE recurrence in elderly outpatients (≥ 75 years old at the time of inclusion) ), with at least one of the known bleeding risk factor, who had a first episode of lower extremity proximal DVT and / or PE, idiopathic or associated with weak or removed risk factors, and who have received standard treatment with any oral anticoagulant drug lasting at least 3 months. The study seeks to verify the safety of the Sulodexide therapy, demonstrating non-inferiority compared to placebo, with an incidence of major bleeding around 1% (upper confidence limit not > 3%).

Condition Venous Thromboembolism, Anticoagulant, Elderly
Treatment Placebo, Sulodexide, Sulodexide and placebo
Clinical Study IdentifierNCT04257487
SponsorArianna Anticoagulazione Foundation
Last Modified on4 October 2022


Yes No Not Sure

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)
Renal failure
Antiplatelet therapy (ASA maximum 140 mg/die)
Frequent falls (>2 /years)
Nonsteroidal anti-inflammatory drug
Liver failure
Previous Stroke
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 Criteria

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
Index event represented by isolated distal DVT or superficial venous thrombosis
thrombolytic therapy
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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