Venous ThromboembolismPhase 3JasonNCT04257487
Sulodexide, VESSEL®, for the Prevention of Recurrent Venous Thromboembolism (The Jason Study)
A Phase 3 study testing Sulodexide in people with Venous Thromboembolism and Anticoagulant, run by Arianna Anticoagulazione Foundation at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Venous Thromboembolism, Anticoagulant, Elderly
- What is being tested?
- Sulodexide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,455 participants
- Where
- 1 siteItaly
- Study dates
- 21 Dec 2020to 2 Jan 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Sulodexide (VESSEL®) for the Prevention of Recurrent Venous Thromboembolism in Elderly Patients After a First Episode of Venous Thrombembolism
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.
Read the 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%).
- Conditions
- Venous Thromboembolism, Anticoagulant, Elderly
- Being tested
- Sulodexide, Sulodexide and placebo, Placebo
- Keywords
- Venous thromboembolism, Elderly, Sulodexide
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulodexideDrug
Also called VESSEL®
2 soft capsules of Vessel® 250 LSU BID for 12 months
Sulodexide and placeboDrug
Also called VESSEL® and placebo
1 soft capsule of Vessel® 250 LSU and 1 soft capsule of placebo BID for 12 months
PlaceboDrug
Also called 2 soft capsule of placebo BDI for 12 months
Sugar pill manufactured to mimic sulodexide 250 LSU
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Active comparator | Sulodexide (Vessel) 2 capsules of 250 LSU BID, for 12 months Receives: Drug: Sulodexide |
| Treatment B | Active comparator | Sulodexide (Vessel) 1 capsule of 250 LSU and 1 indistinguishable placebo capsule BID., for 12 months Receives: Drug: Sulodexide and placebo; Drug: Placebo |
| Treatment C | Placebo comparator | 2 indistinguishable placebo capsules BID, for 12 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Transient ischemic attack (TIA), Stroke, Myocardial infarction will be recorded in all patients
Measured: 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
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
Measured: 12 months
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
Measured: From date of enrollment until the date of first documented event assessed up to 12 months
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
Measured: From date of enrollment until the date of first documented event assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start21 Dec 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion2 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,455 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arianna Anticoagulazione Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Corrado Lodigiani, MD,PhD, Study chair, IRCCS Humanitas, Rozzano (Milano)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257487
- Sponsor's protocol ID
- FAAI2.10.2018
- Other IDs
- 2019-000570-33, 2019
- Acronym
- Jason
- Status last verified
- Jul 2024
- First submitted
- 4 Feb 2020
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32451933
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sulodexide (VESSEL®) for the Prevention of Recurrent Venous Thromboembolism in Elderly Patients After a First Episode of Venous Thrombembolism
- ClinicalTrials.gov ID
- NCT04257487
- Acronym / sponsor ID
- Jason / FAAI2.10.2018
- Conditions
- Venous Thromboembolism, Anticoagulant, Elderly
- Keywords
- Venous thromboembolism, Elderly, Sulodexide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,455 participants (estimated)
- Lead sponsor
- Arianna Anticoagulazione FoundationUniversity, hospital or other
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 2 Jan 2027 (estimated)
- First posted
- 6 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Active comparator | Drug: SulodexideSulodexide (Vessel) 2 capsules of 250 LSU BID, for 12 months |
| Treatment B | Active comparator | Drug: Sulodexide and placebo, Drug: PlaceboSulodexide (Vessel) 1 capsule of 250 LSU and 1 indistinguishable placebo capsule BID., for 12 months |
| Treatment C | Placebo comparator | Drug: Placebo2 indistinguishable placebo capsules BID, for 12 months |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (19 listed)
- 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):
- 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.
Key exclusion criteria (11 listed)
- Patients aged <75 years at the time of the recruitment visit.
- "Provoked" index event, which occurred:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SulodexideAlso: VESSEL®2 soft capsules of Vessel® 250 LSU BID for 12 months | Drug | Treatment A |
| Sulodexide and placeboAlso: VESSEL® and placebo1 soft capsule of Vessel® 250 LSU and 1 soft capsule of placebo BID for 12 months | Drug | Treatment B |
| PlaceboAlso: 2 soft capsule of placebo BDI for 12 monthsSugar pill manufactured to mimic sulodexide 250 LSU | Drug | Treatment B, Treatment C |
Primary outcome
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
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
4 secondary outcomes
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
Presence of severe post-thrombotic syndrome according to Villalta Score
Time frame: 12 months
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Derived from this study: PubMed 32451933Palareti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Corrado Lodigiani, MD,PhD study chair
IRCCS Humanitas, Rozzano (Milano)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sulodexide in people with Venous Thromboembolism and Anticoagulant, run by Arianna Anticoagulazione Foundation at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristina Legnani, BSc, PhD (0039 051 2812339, c.legnani@fondazionearianna.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04257487, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024; AzTrials last refreshed its copy on 8 Nov 2026.