E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066899 |
E.1.2 | Term | Venous thromboembolism |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
- 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) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 36 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 8 |