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

NCT04257487 | Recruiting Phase 3 DMC

• 2 other identifiers: FAAI2.10.20182019-000570-33
• Study Type: interventional
• Target: 1,455
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Venous Thromboembolism; Anticoagulant; Elderly

Keywords

Venous thromboembolism; Elderly; Sulodexide

Outcome Measures

Primary Outcomes (2)

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

  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)

  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 Outcomes (4)

• Number of and rate of thromboembolic events

  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

  12 months

• Number and rate of non major bleeding complications

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

• Number and rate of dead patients (overall mortality)

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

Study Arms (3)

Treatment A

ACTIVE COMPARATOR

Sulodexide (Vessel) 2 capsules of 250 LSU BID, for 12 months

Drug: Sulodexide

Treatment B

ACTIVE COMPARATOR

Sulodexide (Vessel) 1 capsule of 250 LSU and 1 indistinguishable placebo capsule BID., for 12 months

Drug: Sulodexide and placebo; Drug: Placebo

Treatment C

PLACEBO COMPARATOR

2 indistinguishable placebo capsules BID, for 12 months

Drug: Placebo

Interventions

Sulodexide DRUG

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

Also known as: VESSEL®

Treatment A

Sulodexide and placebo DRUG

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

Also known as: VESSEL® and placebo

Treatment B

Placebo DRUG

Sugar pill manufactured to mimic sulodexide 250 LSU

Also known as: 2 soft capsule of placebo BDI for 12 months

Treatment B; Treatment C

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arianna Anticoagulazione Foundation: lead

Study Sites (1)

Corrado Lodigiani

Rozzano, 20089, Italy

RECRUITING

Related Publications (1)

• Palareti G, Legnani C, Antonucci E, Zorzi S, Bignamini AA, Lodigiani C, Tosetto A, Bertu L, Pengo V, Testa S, Ageno W, Prisco D, Prandoni P, Poli D. Design and rationale of a randomized, placebo-controlled trial on the efficacy and safety of sulodexide for extended treatment in elderly patients after a first venous thromboembolism. Intern Emerg Med. 2021 Mar;16(2):359-368. doi: 10.1007/s11739-020-02381-5. Epub 2020 May 25.

  PMID: 32451933 DERIVED

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

glucuronyl glucosamine glycan sulfate

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Corrado Lodigiani, MD,PhD

  IRCCS Humanitas, Rozzano (Milano)

  STUDY CHAIR

Central Study Contacts

Cristina Legnani, BSc, PhD

CONTACT

0039 051 2812339; c.legnani@fondazionearianna.org

Emilia Antonucci, CR

CONTACT

0039 051 4291116; e.antonucci@fondazionearianna.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The subjects enrolled in the study, the experimenters, and the members of the Steering Committee, Adjudication Committee, Data Monitoring and Safety Board will not be aware of the assignment of the 3 treatments following their distribution.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 6, 2020
• Study Start: December 21, 2020
• Primary Completion: December 31, 2025
• Study Completion (Estimated): January 2, 2027
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

IT (1)