Twice-daily oral direct thrombin inhibitor dabigatran etexilate 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)MedDRA version: 6.1Level: PTClassification code 10043634
- Registration Number
- EUCTR2007-002586-12-IT
- Lead Sponsor
- BOEHRINGER ING.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1950
-Patients with confirmed symptomatic PE or proximal DVT 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) -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
-Younger then 18 years of age -Indication for VKA other than DVT and/or PE -Patients in whom anticoagulant treatment for their index PE or DVT should be continued -Active liver disease or liver disease decreasing survival (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT > 3 x ULN -Creatinine clearance < 30 ml/min -Acute bacterial endocarditis -Active bleeding or high risk for bleeding -Uncontrolled hypertension (investigators judgment) -Intake of another experimental drug within the 30 days prior to randomization into the study -Life expectancy < 6 months -Childbearing potential without proper contraceptive measures, pregnancy or breast feeding (proper contraceptive measures are defined according to the note for guidance of non clinical safety studies for the conduct of human trials for pharmaceuticals, CPMP/ICH/286/95 modification; it include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence and vasectomy -Patients with known hypersensivity to dabigatran or any other component of the investigational product -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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method