Use of Sulodexide (VESSEL®) for the prevention of a new episode in elderly patients who have had a first episode of deep vein thrombosis and/or pulmonary embolism

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fondazione Arianna Anticoagulazione

Participant type

Patients

Age range

65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2024-11-12

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

ALFASIGMA SpA

External identifiers

EU CT number

2024-517796-21-00

EudraCT number

2019-000570-33

ClinicalTrials.gov

NCT04257487

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

1)Verify the efficacy of the treatment with two different doses of Sulodexide (Vessel®) (treatment A and treatment B) compared to the indistinguishable placebo (treatment C), in reducing the incidence of VTE relapses in elderly patients (age = 75 years) who have suffered from a recent episode of DVT (proximal lower extremity) and / or PE, by 35% compared to placebo.
2)Verify the safety of the aforementioned therapy, demonstrating non-inferiority compared to placebo, with an incidence of major bleeding around 1% (upper confidence limit not > 3%)

Conditions and MedDRA coding

Prevention of recurrence after a first episode of Venous Thromboembolism (VTE)

Study design 1 period

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Patients with a first event of proximal lower extremity DVT and / or PE,
2. Patients aged =>75 years at the time of enrolment
3. Pazienti with at least one of the known risk factors of bleeding (APPENDIX 1): a.- Hypertension - Previous non-minor bleeding event - Renal failure (< 60 ml/min) - Thrombocytopenia (<100,000 mm3) - Diabetes - Ongoing ASA therapy (maximum 140 mg/day) - Frequent falls (>2 per year) - Use of non-steroidal anti-inflammatory drugs - Liver failure (transaminases > 3 times the upper reference limit) - Previous cerebral stroke - Anemia (hemoglobin< 100 g/L) - Insufficient control of anticoagulant therapy (TTR: Time in range < 60%) - 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 23

1. Patients aged <75 years at the time of the recruitment visit.
2. Active cancer.
3. Index event represented by severe PE, with life threatening risk or which involved thrombolytic therapy.
4. Index event represented by isolated distal DVT or superficial venous thrombosis.
5. Thrombotic event that involved sites other than the deep proximal veins of the lower limbs.
6. Anticoagulant therapy in progress for less than 3 months at the time of enrolment.
7. Discontinuation of anticoagulant therapy for over three months
8. Recurrent episodes of DVT ± PE (do not consider previous superficial venous thrombosis or isolated distal venous thrombosis as an exclusion criteria);
9. Presence of severe post-thrombotic syndrome (Villalta score >15 or presence ofvenous ulcer).
10. Presence of other clinical conditions requiring anticoagulant therapy.
11. Presence of Inferior vena cava (IVC) filter.
12. Patients in therapy with antiplatelet medicinal products other than ASA. The ASA is allowed up to 140 mg / day.
13. All clinical conditions requiring long-term treatment with low molecular weight heparin (LMWH).
14. Presence of Antiphospholipid Antibody Syndrome (according to Sydney criteria)
15. Known carriers of one or more of the following thrombophilic alterations: deficiency of physiological anticoagulants (antithrombin, protein C, protein S).
16. Presence of inflammatory bowel disease in acute;
17. Cardiorespiratory failure (New York Heart Association class 3 or 4).
18. Patients incapacitated or refusing to sign the informed consent.
19. Patients with life expectancy under 1 year.
20. Patients residing in a disadvantaged geographical area.
21. Patient already enrolled in other clinical trials.
22. Pazienti con pressione polmonare sistolica > 40 mm Hg (limite superiore previsto per anziani);
23. Contraindication to Sulodexide (VESSEL®) and Placebo

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Primary efficacy endpoint: -cumulative result of: new episodes of venous thromboembolism (proximal DVT and / or PE), overall mortality due to VTE
2. Primary safety endpoint: - incidence of major bleeding (MB), International Society on Thrombosis and Haemostasis [ISTH] criteria

Secondary endpoints 2

1. Secondary efficacy endpoint: Superficial venin thrombosis; Isolated distal deep vein thrombosis;, Cardiovascular events that involved hospitalization; Death from cardiovascular events (myocardial infarction, ischemic stroke).
2. Secondary safety endpoint: Cumulative incidence of MB and non-major but clinically relevant haemorrhages [NMCRB]

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fondazione Arianna Anticoagulazione

Sponsor organisation

Fondazione Arianna Anticoagulazione

Address

Via Paolo Fabbri 1/3

City

Bologna

Postcode

40138

Country

Italy

Scientific contact point

Organisation

Fondazione Arianna Anticoagulazione

Contact name

Segreteria

Public contact point

Organisation

Fondazione Arianna Anticoagulazione

Contact name

Segreteria

Locations

1 EU/EEA country · 33 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications