Acute symptomatic venous thromboembolism (VTE), i.e. uni- or bilateral deep vein thrombosis (DVT) of the leg involving proximal veins, and/or pulmonary embolism (PE) confirmed by definitive objective clinical test
Conditions
Interventions
Product Name: dabigatrane etexilate
Product Code: BIBR 1048 MS
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: dabigatran etexilate
Sponsors
Boehringer Ingelheim Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Acute symptomatic uni- or bilateral deep vein thrombosis (DVT) of the leg involving proximal veins, and/or pulmonary embolism (PE) confirmed by definitive objective clinical test in patients for whom at least 6 months of anticoagulant therapy is considered appropriate by the investigator 2. Male or female, being 18 years of age or older 3. Written informed consent for study participation 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: 1. Overt symptoms of VTE for longer than 2 weeks prior to enrolment 2. PE satisfying at least one of the following criteria: ? Haemodynamic instability ? Embolectomy is indicated or performed ? Thrombolytic therapy is indicated or performed ? Suspected source of PE is other than the legs 3. Actual or anticipated use of vena cava filter 4. Contraindications to anticoagulant therapy including contraindications to heparins or other alternate approved therapy used for initial treatment, and warfarin 5. Patients who in the investigator’s opinion should not be treated with warfarin 6. Allergy to heparins (including history of heparin induced thrombocytopenia) or other alternate approved therapy used for initial treatment, warfarin or dabigatran, or to one of the excipients included in these medications 7. Patients who in the investigator’s judgement are perceived as having an excessive risk of bleeding, for example because of: ? Hemorrhagic disorder or bleeding diathesis ? Trauma or major surgery within the last month or as long as an excessive risk of bleeding persists after these events, or planned major surgery ? Any of the following intracranial pathologies: neoplasm, arteriovenous malformation or aneurysm ? History of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra articular bleeding ? Gastrointestinal haemorrhage within the past 3 months ? Symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30 days ? Treatment with thrombolytic agents within 14 days before enrolment ? Anticipated need of restricted medication during the treatment period (see CTP Section 4.2.2) ? Known thrombocytopenia (platelet count 2x ULN based on the local lab results obtained at screening and prior to randomisation (or central screening lab if available on time) 12. Liver disease expected to have any potential impact on survival (e.g. acute hepatitis, possibly active hepatitis B, hepatitis C or cirrhosis, but not Gilbert’s syndrome or hepatitis A with complete recovery) 13. Patients who have developed transaminase elevations upon exposure to ximelagatran 14. Severe renal impairment (estimated creatinine clearance = 30 ml/min) 15. Women who are pregnant, nursing, or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study (NOTE: A negative pregnancy test must be obtained for any woman of childbearing potential prior to entry into the study) 16. Participation in another clinical trial with an investigational drug during the last 30 days or previous participation in this study 17. Patients considered unsuitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Composite of recurrent symptomatic venous thromboembolism (VTE) and deaths related to VTE within 6 months. (VTE is defined as the composite incidence of DVT and PE.) ;Main Objective: To determine the comparative efficacy of dabigatran etexilate (150 mg bid), compared to warfarin (INR of 2.0-3.0) for 6 month treatment of acute symptomatic venous thromboembolism (VTE).;Secondary Objective: To determine the comparative safety of dabigatran etexilate (150 mg bid), compared to warfarin (INR of 2.0-3.0) for 6 month treatment of acute symptomatic venous thromboembolism (VTE). | — |
Countries
Austria, Belgium, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Italy, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed