MedTrace Logo

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

NCT04257487 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1455

Last updated 2024-07-31

No results posted yet for this study

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

Interventions

DRUG

Sulodexide

2 soft capsules of Vessel® 250 LSU 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

DRUG

Placebo

Sugar pill manufactured to mimic sulodexide 250 LSU

Sponsors & Collaborators

  • Arianna Anticoagulazione Foundation

    lead OTHER

Principal Investigators

  • Corrado Lodigiani, MD,PhD · IRCCS Humanitas, Rozzano (Milano)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-21
Primary Completion
2025-12-31
Completion
2027-01-02

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04257487 on ClinicalTrials.gov