A phase III, randomised, double blind, parallel-group study of the efficacy and safety of oral dabigatran etexilate (150 mg bid) compared to warfarin (INR 2.0-3.0) for 6 month treatment of acute symptomatic venous thromboembolism, following initial treatment (5-10 days) with a parenteral anticoagulant approved for this indication. RE-COVER - RE-COVER

Conditions: 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

Registration Number: EUCTR2005-001999-12-DK

Lead Sponsor: Boehringer Ingelheim BV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2550

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

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 < 100•109•L-1)
8. Known anaemia (haemoglobin < 100 g•L-1)
9. Need of anticoagulant treatment for disorders other than VTE
10. Recent unstable cardiovascular disease, such as uncontrolled hypertension at the time of enrolment (investigator’s judgement), acute bacterial endocarditis or history of myocardial infarction within the last 3 months
11. Elevated AST or ALT > 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 for inclusion by the investigator, e.g. because considered unreliable to comply with the requirements for follow-up during the study and/or compliance with study drug administration, has a life expectancy less than the expected duration of the trial due to concomitant disease, or has any condition which in the opinion of the investigator would not allow safe participation in the study (e.g., drug addiction, alcohol abuse)
18. In case of anticipated study related diagnostic procedures requir

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).;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.)<br>

Secondary Outcome Measures