Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04257487

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Venous Thromboembolism Anticoagulant Cardiovascular Diseases Elderly Embolism and Thrombosis Thromboembolism Vascular Diseases

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Corrado Lodigiani

Rozzano, 20089, Italy

Location status: Recruiting

About this study

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%).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)
  • 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

Treatment and study plan

Sulodexide

Drug

2 soft capsules of Vessel® 250 LSU BID for 12 months

Other names: VESSEL®

Sulodexide and placebo

Drug

1 soft capsule of Vessel® 250 LSU and 1 soft capsule of placebo BID for 12 months

Other names: VESSEL® and placebo

Placebo

Drug

Sugar pill manufactured to mimic sulodexide 250 LSU

Other names: 2 soft capsule of placebo BDI for 12 months

Primary outcomes

  1. Number and rate of patients with confirmed recurrent VTE and VTE-related death (efficacy).

    Time frame: From date of enrollment until the date of first documented event assessed up to 12 months

    The occurrence of proximal deep vein thrombosis with or without pulmonary embolism (new or recurrent episode) wil be recorded in all patients

  2. Number and rate of major Bleeding events (defined according to International Society on Thrombosis and Haemostasis guidelines (safety)

    Time frame: From date of enrollment until the date of first documented event assessed up to 12 months

    Fatal bleeding; intracranial; intraspinal; intraocular; pericardial; intra-articular; intramuscular with compartment syndrome; retroperitoneal,; acute clinically overt bleeding will be recorded in all patients

Secondary outcomes

  1. Number of and rate of thromboembolic events

    Time frame: From date of enrollment until the date of first documented event assessed up to 12 months

    Transient ischemic attack (TIA), Stroke, Myocardial infarction will be recorded in all patients

  2. Presence of severe post-thrombotic syndrome according to Villalta Score

    Time frame: 12 months

    Patient with deep vein thrombosis as index event will be evaluated, at the and of follow-up, applying Villalta score, commonly used to diagnose post-thrombotic syndrome in the subacute phase of thrombosis. The presence of venous ulcer of the leg or a score > of 15 points indicate the occurrence of severe post-thrombotic syndrome. The maximum score is 33. The score from 5 to 9 points indicate mild post-thrombotic syndrome and from 10 to 15 points indicate moderate post-thrombotic syndrome

  3. Number and rate of non major bleeding complications

    Time frame: From date of enrollment until the date of first documented event assessed up to 12 months

    In all patients will be recorded any sign or symptom of hemorrhage that does not fit the criteria for the definition of major bleeding but does meet at least one of the following criteria: 1)requiring medical intervention by a healthcare professional; 2) leading to hospitalization or increased level of care;3) prompting a face to face evaluation

  4. Number and rate of dead patients (overall mortality)

    Time frame: From date of enrollment until the date of first documented event assessed up to 12 months

    VTE-related death; cardiovascular related-death; bleeding-related death; death for: cancer, infectious disease and unknown cause; sudden death will be recorded in all patients

Study contacts

Contact information is provided by the study sponsor or research team.

Cristina Legnani, BSc, PhD

CONTACT

[email protected]

0039 051 2812339

Emilia Antonucci, CR

CONTACT

[email protected]

0039 051 4291116

Sponsors and collaborators

Lead sponsor

Arianna Anticoagulazione Foundation

Other

Registry information

Official study title

Sulodexide (VESSEL®) for the Prevention of Recurrent Venous Thromboembolism in Elderly Patients After a First Episode of Venous Thrombembolism

Acronym: Jason

Important dates

Study start
2020
Primary completion
2025
Study completion
2027
First posted
Feb 6, 2020
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.