Twice-daily oral direct thrombin inhibitor dabigatran in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embolism. - Re-Sonate

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1800

Inclusion Criteria

1. Patients with confirmed symptomatic PE or proximal DVT of the legs who have been treated for 6 to 18 months* with therapeutic dosages (intended INR between 2 - 3) of an oral VKA (e.g., warfarin, acenocoumarol, phenprocoumon, or fluindione) or RE-COVER study medication up to the moment for the current study.

*bridging therapy for any reason within the 6 - 18 months of VKA therapy is allowed for a maximum of 30 days

2. Written informed consent

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. Younger then 18 years of age
2. Indication for VKA other than DVT and/or PE
3. Patients in whom anticoagulant treatment for their index PE or DVT should be
continued
4. Active liver disease or liver disease decreasing survival (e.g. acute hepatitis,
chronic active hepatitis, cirrhosis) or ALAT > 3 x ULN
5. Creatinine clearance < 30 ml/min
6. Acute bacterial endocarditis
7. Patients who in the investigator’s judgement are perceived as having an excessive risk of bleeding, for example because of anticipated need of quinidine or other restricted medication during the treatment period
8. Uncontrolled hypertension (investigators judgement)
9. Intake of another experimental drug within the 30 days prior to randomization
into the study with the exception of patients participating in RE-COVER (BI study 1160.53)
10. Life expectancy < 6months
11. Childbearing potential without proper contraceptive measures*, pregnancy or
breast feeding
*proper contraceptive measures are defined as a method of contraception with a failure rate < 1 % during the course of the study (including the observational period). These methods of contraception according to the note for guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP/ICH/286/95, modification) include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence and vasectomy
12. Patients with known hypersensitivity to dabigatran or any other component of the
investigational product
13. Patients deemed unsuitable for inclusion by the investigator, because
considered unreliable to comply with the requirements of the study and/or
compliance with study drug administration, or because having any condition or
disease which in the opinion of the investigator would not allow safe
participation in the study
14. Patients with known active cancer
15. Patients with a contraindication to systemic anticoagulation

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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