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: 9.1 Level: LLT Classification code 10049909 Term: Venous thromboembolism prophylaxis
Conditions
Interventions
Product Name: Dabigatran etexilate
Product Code: BIBR 1048 MS
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: dabigatran etexilate
CAS Number: 211915-06-9
Current Sponsor code: BIBR 1048 MS
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Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary efficacy objective is to evaluate whether dabigatran etexilate is superior to placebo in the 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).;Secondary Objective: ;Primary end point(s): The primary efficacy outcome is symptomatic recurrent VTE, i.e., the composite of recurrent DVT or fatal or non-fatal PE | — |
Countries
Austria, Belgium, Czech Republic, Estonia, Germany, Italy, Latvia, Lithuania, Netherlands, Poland, Sweden
Outcome results
None listed