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

July 30, 2024 updated by: Arianna Anticoagulazione Foundation

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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%).

Study Type

Interventional

Enrollment (Estimated)

1455

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Rozzano, Italy, 20089
        • Recruiting
        • Corrado Lodigiani

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with a first event of proximal lower extremity DVT and / or PE, idiopathic or associated with weak or removed risk factors.
  2. Patients aged ≥75 years at the time of enrolment

  3. Patients with at least one of the known risk factors of bleeding (APPENDIX 1):

    1. Hypertension
    2. Renal failure
    3. Thrombocytopenia
    4. Diabetes
    5. Antiplatelet therapy (ASA maximum 140 mg/die)
    6. Frequent falls (>2 /years)
    7. Nonsteroidal anti-inflammatory drug
    8. Liver failure
    9. Previous Stroke
    10. Anemia
    11. Poor anticoagulant control
    12. Alcohol abuse
  4. Patients of both sexes.
  5. 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.
  6. Patients with no other AT indications.
  7. Patients capable and able to provide informed consent

Exclusion Criteria:

  1. Patients aged <75 years at the time of the recruitment visit.

  2. "Provoked" index event, which occurred:

    • Within 3 months of surgery or major trauma,
    • Bed Rest > 4 days,
    • Cast / immobility within 3 months.
  3. Index event represented by severe PE, with life threatening risk or treated with thrombolytic therapy.
  4. Index event represented by isolated distal DVT or superficial venous thrombosis.
  5. Thrombotic event in sites other than the deep proximal veins of the lower limbs.
  6. Anticoagulant therapy for less than 3 months at the time of enrolment.
  7. Discontinuation of anticoagulant therapy for over thirty days at the time of enrolment
  8. Recurrent episodes of DVT ± PE

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment A
Sulodexide (Vessel) 2 capsules of 250 LSU BID, for 12 months
Drug: Sulodexide
2 soft capsules of Vessel® 250 LSU BID for 12 months
Other Names:
  • VESSEL®
Active Comparator: Treatment B
Sulodexide (Vessel) 1 capsule of 250 LSU and 1 indistinguishable placebo capsule BID., for 12 months
Drug: Sulodexide and placebo
1 soft capsule of Vessel® 250 LSU and 1 soft capsule of placebo BID for 12 months
Other Names:
  • VESSEL® and placebo
Drug: Placebo
Sugar pill manufactured to mimic sulodexide 250 LSU
Other Names:
  • 2 soft capsule of placebo BDI for 12 months
Placebo Comparator: Treatment C
2 indistinguishable placebo capsules BID, for 12 months
Drug: Placebo
Sugar pill manufactured to mimic sulodexide 250 LSU
Other Names:
  • 2 soft capsule of placebo BDI for 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of enrollment until the date of first documented event assessed up to 12 months
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
From date of enrollment until the date of first documented event assessed up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of enrollment until the date of first documented event assessed up to 12 months
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
12 months
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
From date of enrollment until the date of first documented event assessed up to 12 months
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
From date of enrollment until the date of first documented event assessed up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arianna Anticoagulazione Foundation

Investigators

  • Study Chair: Corrado Lodigiani, MD,PhD, IRCCS Humanitas, Rozzano (Milano)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2020

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

January 2, 2027

Study Registration Dates

First Submitted

February 4, 2020

First Submitted That Met QC Criteria

February 4, 2020

First Posted (Actual)

February 6, 2020

Study Record Updates

Last Update Posted (Actual)

July 31, 2024

Last Update Submitted That Met QC Criteria

July 30, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAAI2.10.2018
  • 2019-000570-33 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Venous Thromboembolism

Clinical Trials on Sulodexide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe