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

INTERVENTION: Trade Name: VESSEL Pharmaceutical Form: Capsule, soft INN or Proposed INN: Sulodexide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25‐ Pharmaceutical form of the placebo: Capsule, soft Route of administration of the placebo: Oral use CONDITION: 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: 9.1 Level: LLT Classification code 10014522 PRIMARY OUTCOME: 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 Primary end point(s): ‐New episode of proximal deep vein thrombosis of lower limb ‐New episode of pulmonary embolism ‐Death due to documented new VTE episode complications 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) 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