Multicentre, randomised, double blind, placebo controlled study on long-term treatment with Sulodexide for prevention of recurrent DVT in patients with venous thromboembolism. - SURVET study

Phase 1

Conditions: Patients who have suffered a first-ever symptomatic unprovoked VTE episode (proximal deep Vein thrombosis and/or pulmonary embolism) who receive initial treatment with unfractioned or low-molecular-weight heparin (or effective alternative) and warfarin for 3-12 months
MedDRA version: 12.1Level: LLTClassification code 10066899Term: Venous thromboembolism

Registration Number: EUCTR2009-016923-77-PT

Lead Sponsor: ALFA WASSERMANN SPA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 617

Inclusion Criteria

- Age =18 years, of both sexes and any ethnical group
- Patients treated with anticoagulant therapy (with VKA) for 3-12 months due to a documented previous unprovoked (defined as not triggered by: major/orthopaedic surgery, immobilization due to setting for more than 4 days and due to plaster, major trauma) DVT or PE
- Patients who stopped VKA therapy from more than 1 week and less than 3 months
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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

Exclusion Criteria

- Secondary VTE (due to major/orthopaedic surgery, immobilization due to setting for more than 4 days and due to plaster, major trauma)
- Current pregnancy or during puerperium (first 6 weeks after birth) at the time of examination for inclusion in the study
- Pulmonary embolism associated with shock or lifethreatening prolonged hypotension or persistence of pulmonary hypertension after pulmonary embolism
- Two or more documented episodes of proximal VTE of lower limbs and/or pulmonary embolism
- DVT in areas other than lower limbs
- Isolated distal DVT (thrombosis of calf)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether Sulodexide is more effective than placebo for the prevention of recurrent symptomatic venous thromboembolism when given for two years after the initial 3-12 months of oral anticoagulant therapy in patients with unprovoked (defined as not triggered by: major/orthopaedic surgery, immobilization due to setting for more than 4 days and due to plaster, major trauma) venous thromboembolism;Secondary Objective: -Time to VTE new episode<br>-Isolated distal deep vein thrombosis of the legs<br>-Superficial vein thrombosis of the legs<br>-Post thrombotic syndrome<br>-Incidence of major vascular events (Acute Myocardial Infarction, Stroke);Primary end point(s): Compare the proportion of the observed events i.e. CONFIRMED VTE RECURRENCE AS<br>-New episode of proximal deep vein thrombosis of lower limb<br>-New episode of pulmonary embolism<br>-Death due to documented new VTE episode complications

Secondary Outcome Measures

Name	Time	Method

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