Acute symptomatic VTE VTE is defined as the composite incidence of Deep Vein Thrombosis of the leg (including the inferior caval vein) and Pulmonary Embolism. MedDRA version: 9.1 Level: LLT Classification code 10037377 Term: Pulmonary embolism MedDRA version: 9.1 Level: LLT Classification code 10047251 Term: Venous thrombosis deep (limbs)
Conditions
Interventions
Product Name: dabigatran eteilate
Product Code: BIBR 1048
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: dabigatran etexilate
CAS Number: 211915-06-9
Current Sponsor code: BI1048MS
Other desc
Sponsors
Boehringer Ingelheim Austia Gm.b.H
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to investigate the efficacy of dabigatran etexilate 150 mg bid administered orally compared to warfarin PRN to maintain an INR of 2.0-3.0 for a 6 month treatment period according to the study endpoints in patients with acute symptomatic Venous Thromboembolic Event (VTE is defined as the composite incidence of Deep Vein Thrombosis of the leg and pulmonary embolism.);Secondary Objective: The investigation of other selected efficacy aspects and safety are regarded as secondary objective of this trial.;Primary end point(s): A composite of recurrent symptomatic VTE and deaths related to VTE within 6 months. VTE is defined as the composite incidence of DVT of the leg (including the inferior caval vein) and PE. All recurrent VTE require objective verification by definitive diagnostic evaluation: • Any suspected DVT must be confirmed by venous compression ultrasonography (CUS) or venography. • Any suspected PE must be confirmed by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) CT. In case of death, autopsy is an additional way to confirm VTE. | — |
Countries
Bulgaria, Czech Republic, Denmark, France, Hungary, Italy, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed