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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04257487
Recruitment Status : Recruiting
First Posted : February 6, 2020
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
Arianna Anticoagulazione Foundation

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.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Anticoagulant Elderly Drug: Sulodexide Drug: Sulodexide and placebo Drug: Placebo Phase 3

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%).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1455 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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
Official Title: Sulodexide (VESSEL®) for the Prevention of Recurrent Venous Thromboembolism in Elderly Patients After a First Episode of Venous Thrombembolism
Estimated Study Start Date : May 2, 2020
Estimated Primary Completion Date : June 2, 2023
Estimated Study Completion Date : December 2, 2023

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 Name: 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 Name: VESSEL® and placebo

Drug: Placebo
Sugar pill manufactured to mimic sulodexide 250 LSU
Other Name: 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 Name: 2 soft capsule of placebo BDI for 12 months




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04257487


Contacts
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Contact: Cristina Legnani, BSc, PhD 0039 051 2812339 c.legnani@fondazionearianna.org
Contact: Emilia Antonucci, CR 0039 051 4291116 e.antonucci@fondazionearianna.org

Locations
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Italy
Corrado Lodigiani Recruiting
Rozzano, Italy, 20089
Sponsors and Collaborators
Arianna Anticoagulazione Foundation
Investigators
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Study Chair: Corrado Lodigiani, MD,PhD IRCCS Humanitas, Rozzano (Milano)
  Study Documents (Full-Text)

Documents provided by Arianna Anticoagulazione Foundation:

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Responsible Party: Arianna Anticoagulazione Foundation
ClinicalTrials.gov Identifier: NCT04257487    
Other Study ID Numbers: FAAI2.10.2018
2019-000570-33 ( EudraCT Number )
First Posted: February 6, 2020    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arianna Anticoagulazione Foundation:
Venous thromboembolism
Elderly
Sulodexide
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Glucuronyl glucosamine glycan sulfate
Anticoagulants
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs