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

  • STATUS
    Recruiting
  • End date
    Dec 2, 2023
  • participants needed
    1455
  • sponsor
    Arianna Anticoagulazione Foundation
Updated on 26 March 2021
diabetes
thrombosis
clot
hypertension
stroke
anticoagulants
thrombocytopenia
anticoagulant therapy
secondary prevention
venous thromboembolism
deep vein thrombosis
pulmonary embolism

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.

Description

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%).

Details
Condition Venous Thromboembolism, Anticoagulants, Aged, Thromboembolism, anticoagulant, blood thinner, agents, anticoagulant, anticoagulation agents, blood thinners, anticoagulant drugs, anti-coagulant
Treatment Placebo, Sulodexide, Sulodexide and placebo
Clinical Study IdentifierNCT04257487
SponsorArianna Anticoagulazione Foundation
Last Modified on26 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 75 yrs?
Gender: Male or Female
Do you have any of these conditions: Venous Thromboembolism or Thromboembolism or Anticoagulants or Aged?
Do you have any of these conditions: agents, anticoagulant or Thromboembolism or anti-coagulant or Aged or blood thinners or anticoagulant drugs or anticoagulation agents or Anticoagulant...?
Do you have any of these conditions: anti-coagulant or Thromboembolism or agents, anticoagulant or anticoagulation agents or blood thinners or anticoagulant drugs or Aged or blood thinner...?
Do you have any of these conditions: anti-coagulant or agents, anticoagulant or blood thinners or Aged or blood thinner or anticoagulant drugs or anticoagulation agents or Thromboembolism...?
Do you have any of these conditions: blood thinners or Anticoagulants or anticoagulation agents or anticoagulant drugs or Venous Thromboembolism or anticoagulant or Thromboembolism or age...?
Do you have any of these conditions: blood thinner or Thromboembolism or Anticoagulants or agents, anticoagulant or anticoagulant drugs or anti-coagulant or anticoagulation agents or bloo...?
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 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 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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