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

• Conditions: long-term prevention of recurrent symptomatic venous thromboembolism (VTE) in patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) who completed 6 to 18 months of treatment with a vitamin K antagonist (VKA).; MedDRA version: 9.1Level: LLTClassification code 10049909Term: Venous thromboembolism prophylaxis

• Registration Number: EUCTR2007-002586-12-PL
• Lead Sponsor: Boehringer Ingelheim Pharma GesmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-26
• Last Update Posted: 14 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1800

Inclusion Criteria

1. Patients with confirmed symptomatic PE or proximal DVT who have been treated
for 6 to 18 months with an oral VKA (e.g., warfarin, acenocoumarol,
phenprocoumon, or fluindione)

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. Active bleeding or high risk for bleeding.
8. Uncontrolled hypertension (investigators judgement)
9. Intake of another experimental drug within the 30 days prior to randomization
into the study
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 hypersensivity 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified