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

Phase 1

Conditions: Venous Thromboembolism
MedDRA version: 12.1Level: LLTClassification code 10066899Term: Venous thromboembolism

Registration Number: EUCTR2009-016923-77-SK

Lead Sponsor: Alfa Wassermann SpA

Brief Summary: Not available

Detailed Description: Not available

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 sitting for more than 4 days and due to plaster, major trauma) DVT or PE
(*)Proximal deep vein thrombosis (DVT) should have been diagnosed on the basis of
evidence of thrombus in the popliteal or more proximal veins on compression
ultrasonography or contrast venography, and pulmonary embolism by ventilation–
perfusion lung scanning or helical computed tomography
• Ability to provide informed consent
• The signed informed consent must be obtained before starting any study procedure
• Female of a fertile age must have a negative urine pregnancy test and they should
use a proper contraceptive method (IUD, barrier method; no oral contraceptives)
during the entire duration of the trial
• 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 sitting 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)
• Oral contraceptives taking
• Patients who stopped VKA therapy from less than 1 week and more than 3 months
• Solid neoplasia or blood disease in active phase or requiring
chemotherapy/radiotherapy
• Antiphospholipid antibody syndrome as demonstrated by Sydney criteria;
• Antithrombin congenital deficit
• Need to continue VKA for whatever reason (linked to thrombotic event or other
clinical indications)
• Severe cardio-respiratory insufficiency (Class NYHA 3 or 4)
• Limited life expectancy
• Geographically inaccessible location
• Inability or refusal to give consent
• Participation in another clinical trial with investigational drugs within the last 4
weeks before screening or during the present trial period
• Known hypersensitivity towards glycosaminoglycans