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

• 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: 9.1Level: LLTClassification code 10014522

• Registration Number: EUCTR2009-016923-77-IT
• Lead Sponsor: ALFA WASSERMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-30
• Last Update Posted: 14 September 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 784

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 life threatening 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