Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Anticoagulant
  • Elderly
  • Venous Thromboembolism
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: 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.Primary Purpose: Prevention

Participation Requirements

Age
Between 75 years and 125 years
Gender
Both males and females

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...

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%).

Tracking Information

NCT #
NCT04257487
Collaborators
Not Provided
Investigators
Study Chair: Corrado Lodigiani, MD,PhD IRCCS Humanitas, Rozzano (Milano)
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