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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-016923-77-SK

Enrollment

784

Registered

2010-05-25

Start date

2010-08-25

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Thromboembolism MedDRA version: 12.1 Level: LLT Classification code 10066899 Term: Venous thromboembolism

Interventions

Trade Name: VESSEL DUE F Pharmaceutical Form: Capsule, soft INN or Proposed INN: SULODEXIDE CAS Number: 57821291 Concentration unit: Other Concentration type: equal Concentration number: 250 LSU- Phar

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether Sulodexide is more effective than placebo for the prevention of recurrent symptomatic venous thromboembolism when given for two year 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 sitting for more than 4 days and due to plaster, major trauma) venous thromboembolism.;Secondary Objective: - Time to VTE new episode - Isolated distal deep vein thrombosis of the legs - Superficial vein thrombosis of the legs - Post thrombotic syndrome - Incidence of major vascular events (Acute Myocardial Infarction, Stroke);Primary end point(s): Confirmed VTE recurrence as • New episode of proximal deep vein thrombosis of lower limb • New episode of pulmonary embolism • Death due to documented new VTE episode complications To measure the residual thrombosis extension and to confirm new possible episodes of DVT of the lower limbs (primary objective), all patients included in the study (with DVT and/or PE), and who have signed the informed consent.	—

Measure

Time frame

Main Objective: To determine whether Sulodexide is more effective than placebo for the prevention of recurrent symptomatic venous thromboembolism when given for two year 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 sitting for more than 4 days and due to plaster, major trauma) venous thromboembolism.;Secondary Objective: - Time to VTE new episode - Isolated distal deep vein thrombosis of the legs - Superficial vein thrombosis of the legs - Post thrombotic syndrome - Incidence of major vascular events (Acute Myocardial Infarction, Stroke);Primary end point(s): Confirmed VTE recurrence as • New episode of proximal deep vein thrombosis of lower limb • New episode of pulmonary embolism • Death due to documented new VTE episode complications To measure the residual thrombosis extension and to confirm new possible episodes of DVT of the lower limbs (primary objective), all patients included in the study (with DVT and/or PE), and who have signed the informed consent.

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Countries

Czech Republic, Italy, Poland, Portugal, Slovakia

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026