Sulodexide (VESSEL®) for the prevention of a recurrent episode of deep vein thrombosis and/or pulmonary embolism in elderly patients

Phase 1

• Conditions: Prevention of recurrence after a first episode of VTE; MedDRA version: 21.0Level: LLTClassification code 10043640Term: Thrombosis venousSystem Organ Class: 100000004866; MedDRA version: 20.0Level: LLTClassification code 10034191Term: PESystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2019-000570-33-IT
• Lead Sponsor: FONDAZIONE ARIANNA ANTICOAGULAZIONE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-17
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1455

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)Pazienti with at lesast one of the known risk factors of bleeding (APPENDIX 1):
a.Hypertension
b.Renal failure
c.Thrombocytopenia
d.Diabetes
e.Antiplatelet therapy (ASA maximum 140 mg/die)
f.Frequent falls (>2 /years)
g.Nonsteroidal anti-inflammatory drug
h.Liver failure
i.Previous Stroke
j.Anemia
k.Poor anticoagulant control
l.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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1455

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 (general anesthesia> 30 min)
•Relapse > 4 days,
•Cast / immobilization within 3 months.
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.
9)Presence of severe post-thrombotic syndrome (Villalta score >15 or presence ofvenous ulcer).
10)Presence of other clinical conditions requiring anticoagulant therapy.
11)Active cancer.
12)Presence of Inferior vena cava (IVC) filter.
13)Known bleeding diatheses.
14)Patients in therapy with antiplatelet medicinal products other than ASA. The ASA is allowed up to 140 mg / day.
15)All clinical conditions requiring long-term treatment with low molecular weight heparin (LMWH).
16)Presence of Antiphospholipid Antibody Syndrome (according to Sydney criteria)
17)Known carriers of one or more of the following thrombophilic alterations: deficiency of physiological anticoagulants (antithrombin, protein C, protein S).
18)Presence of chronic diseases in acute or active phase (e.g.: inflammatory bowel disease)
19)Cardiorespiratory failure (New York Heart Association class 3 or 4).
20)Patients incapacitated or refusing to sign the informed consent.
21)Patients with life expectancy under 1 year.
22)Patients residing in a disadvantaged geographical area.
23)Patient already enrolled in other clinical trials.
24)Patients with systolic pulmonary artery pressure > 40 mm hg (upper limit for elderly).
25)Contraindication to Sulodexide (VESSEL®) and Placebo

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.<br>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%);Secondary Objective: N.A:;Primary end point(s): •Primary efficacy endpoint: <br>-cumulative result of: new episodes of venous thromboembolism (proximal DVT and / or PE), overall mortality due to VTE<br>•Primary safety endpoint: <br>-incidence of major bleeding (MB), International Society on Thrombosis and Haemostasis [ISTH] criterion);Timepoint(s) of evaluation of this end point: During the entire duration of follow-up

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Secondary efficacy endpoint:Cardiovascular events that involved hospitalization;<br>-Death from cardiovascular events (myocardial infarction, ischemic stroke).<br>•Secondary safety endpoint:<br>-Cumulative incidence of MB and non-major but clinically relevant haemorrhages [NMCRB];Timepoint(s) of evaluation of this end point: During the entire duration of follow-up