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 for at least 5 days with a parenteral anticoagulant approved for this indication. RE-COVER II - RE-COVER II

Conditions: Acute symptomatic VTEVTE is defined as the composite incidence of Deep Vein Thrombosis of the leg (including the inferior caval vein) and Pulmonary Embolism.
MedDRA version: 9.1Level: LLTClassification code 10037377Term: Pulmonary embolism
MedDRA version: 9.1Level: LLTClassification code 10047251Term: Venous thrombosis deep (limbs)

Registration Number: EUCTR2007-002631-86-SK

Lead Sponsor: Boehringer Ingelheim Pharma Ges mbH

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 DVT of the leg involving proximal veins, and/or
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. In case of anticipated study related diagnostic procedures requiring contrast medium:
• Elevated serum creatinine, which in the investigator’s opinion contraindicates
these examinations
• Known allergy to radio opaque contrast media or iodine, which in the
investigator’s opinion contraindicates these examinations
8. Patients who in the investigator’s judgement are perceived as having an excessive risk of bleeding (examples listed in the protocol)
9. Known anaemia (haemoglobin < 100 g·L-1)
10. Need of anticoagulant treatment for disorders other than VTE
11. 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
12. Elevated Aspartate-aminotransferase (AST) or Alanine-aminotransferase (ALT) > 3xULN based on the local lab results obtained at screening and prior to randomisation
13. 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)
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
16. 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)
17. Participation in another clinical trial with an investigational drug during the last 30
days or previous participation in this study or RE-COVER I (1160.53)