Back to resultsSulodexide, VESSEL®, for the Prevention of Recurrent Venous Thromboembolism (The Jason Study) (Jason)
Primary Purpose
Venous Thromboembolism, Anticoagulant, Elderly
Status
Recruiting
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Sulodexide
Sulodexide and placebo
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Venous Thromboembolism focused on measuring Venous thromboembolism, Elderly, Sulodexide
Eligibility Criteria
Inclusion Criteria:
- 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
- Patients of both sexes.
- 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.
- Patients with no other AT indications.
- Patients capable and able to provide informed consent
Exclusion Criteria:
- 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
Sites / Locations
- Corrado LodigianiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Treatment A
Treatment B
Treatment C
Arm Description
Sulodexide (Vessel) 2 capsules of 250 LSU BID, for 12 months
Sulodexide (Vessel) 1 capsule of 250 LSU and 1 indistinguishable placebo capsule BID., for 12 months
2 indistinguishable placebo capsules BID, for 12 months
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Number of and rate of thromboembolic events
Transient ischemic attack (TIA), Stroke, Myocardial infarction will be recorded in all patients
Presence of severe post-thrombotic syndrome according to Villalta Score
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
Number and rate of non major bleeding complications
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
Number and rate of dead patients (overall mortality)
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
Full Information
NCT ID
NCT04257487
First Posted
February 4, 2020
Last Updated
July 19, 2022
Sponsor
Arianna Anticoagulazione Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04257487
Brief Title
Sulodexide, VESSEL®, for the Prevention of Recurrent Venous Thromboembolism (The Jason Study)
Acronym
Jason
Official Title
Sulodexide (VESSEL®) for the Prevention of Recurrent Venous Thromboembolism in Elderly Patients After a First Episode of Venous Thrombembolism
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 21, 2020 (Actual)
Primary Completion Date
September 2, 2023 (Anticipated)
Study Completion Date
December 2, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arianna Anticoagulazione Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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%).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism, Anticoagulant, Elderly
Keywords
Venous thromboembolism, Elderly, Sulodexide
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
1455 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment A
Arm Type
Active Comparator
Arm Description
Sulodexide (Vessel) 2 capsules of 250 LSU BID, for 12 months
Arm Title
Treatment B
Arm Type
Active Comparator
Arm Description
Sulodexide (Vessel) 1 capsule of 250 LSU and 1 indistinguishable placebo capsule BID., for 12 months
Arm Title
Treatment C
Arm Type
Placebo Comparator
Arm Description
2 indistinguishable placebo capsules BID, for 12 months
Intervention Type
Drug
Intervention Name(s)
Sulodexide
Other Intervention Name(s)
VESSEL®
Intervention Description
2 soft capsules of Vessel® 250 LSU BID for 12 months
Intervention Type
Drug
Intervention Name(s)
Sulodexide and placebo
Other Intervention Name(s)
VESSEL® and placebo
Intervention Description
1 soft capsule of Vessel® 250 LSU and 1 soft capsule of placebo BID for 12 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
2 soft capsule of placebo BDI for 12 months
Intervention Description
Sugar pill manufactured to mimic sulodexide 250 LSU
Primary Outcome Measure Information:
Title
Number and rate of patients with confirmed recurrent VTE and VTE-related death (efficacy).
Description
The occurrence of proximal deep vein thrombosis with or without pulmonary embolism (new or recurrent episode) wil be recorded in all patients
Time Frame
From date of enrollment until the date of first documented event assessed up to 12 months
Title
Number and rate of major Bleeding events (defined according to International Society on Thrombosis and Haemostasis guidelines (safety)
Description
Fatal bleeding; intracranial; intraspinal; intraocular; pericardial; intra-articular; intramuscular with compartment syndrome; retroperitoneal,; acute clinically overt bleeding will be recorded in all patients
Time Frame
From date of enrollment until the date of first documented event assessed up to 12 months
Secondary Outcome Measure Information:
Title
Number of and rate of thromboembolic events
Description
Transient ischemic attack (TIA), Stroke, Myocardial infarction will be recorded in all patients
Time Frame
From date of enrollment until the date of first documented event assessed up to 12 months
Title
Presence of severe post-thrombotic syndrome according to Villalta Score
Description
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
Time Frame
12 months
Title
Number and rate of non major bleeding complications
Description
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
Time Frame
From date of enrollment until the date of first documented event assessed up to 12 months
Title
Number and rate of dead patients (overall mortality)
Description
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
Time Frame
From date of enrollment until the date of first documented event assessed up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Patients of both sexes.
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.
Patients with no other AT indications.
Patients capable and able to provide informed consent
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cristina Legnani, BSc, PhD
Phone
0039 051 2812339
Email
c.legnani@fondazionearianna.org
First Name & Middle Initial & Last Name or Official Title & Degree
Emilia Antonucci, CR
Phone
0039 051 4291116
Email
e.antonucci@fondazionearianna.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corrado Lodigiani, MD,PhD
Organizational Affiliation
IRCCS Humanitas, Rozzano (Milano)
Official's Role
Study Chair
Facility Information:
Facility Name
Corrado Lodigiani
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
32451933
Citation
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.
Results Reference
derived
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Sulodexide, VESSEL®, for the Prevention of Recurrent Venous Thromboembolism (The Jason Study)
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