Treatment and secondary prevention of venous thromboembolism in patients with acute symptomatic deep- vein thrombosis or pulmonary embolism
Conditions
Interventions
Product Name: rivaroxaban
Product Code: BAY 59-7939
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: rivaroxaban
CAS Number: 366789-02-8
Current Sponsor code: BAY 59-7939
Concentration
Sponsors
Bayer Healthcare AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For Einstein-DVT: confirmed acute symptomatic proximal DVT without symptomatic PE , or For Einstein-PE: confirmed acute symptomatic PE with or without symptomatic DVT 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. Legal lower age limitations (country specific) 2. Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE 3. Other indication for VKA than DVT and/or PE 4. More than 48 hours pre-randomization treatment with therapeutic dosages of anticoagulant treatment or more than a single dose of VKA prior to randomization. 5. Participation in another pharmacotherapeutic study within 30 days 6. Creatinine clearance 3 x ULN 8. Bacterial endocarditis 9. Life expectancy 180 mmHg or diastolic blood pressure >110 mmHg 12. Childbearing potential without proper contraceptive measures, pregnancy or breast feeding 13. Any other contraindication listed in the local labeling of warfarin, acenocoumarol, or enoxaparin 14. Concomitant use of strong CYP3A4 inhibitors (e.g., HIV protease inhibitors, systemic ketokonazole) or strong CYP3A4 inducers like rifampicin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 occurring during the 3-, 6,- and 12-month study treatment periods. The following definitions are applied by the CIAC to confirm a suspected episode of symptomatic recurrent PE/DVT. (3;4) 1. Suspected (recurrent) PE with one of the following findings • a (new) intraluminal filling defect in segmental or more proximal branches on spiral CT scan • a (new) intraluminal filling defect or an extension of an existing defect or a new sudden cutoff of vessels more than 2.5 mm in diameter on the pulmonary angiogram • a (new) perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan (VPLS) • inconclusive sCT, pulmonary angiography or VPLS with demonstration of DVT in the lower extremities by compression ultrasound or venography. or 2. Suspected (recurrent) DVT with one of the following findings if there were no previous DVT investigations: • abnormal compression ultrasound (CUS) • an intraluminal filling defect on venography if there was a DVT investigation at screening: • abnormal CUS where compression had been normal or, if non-compressible during screening, a substantial increase (4 mm or more) in diameter of the thrombus during full compression • an extension of an intraluminal filling defect, or a new intraluminal filling defect or an extension of non-visualization of veins in the presence of a sudden cut-off on venography 3. Fatal PE • PE based on objective diagnostic testing, autopsy, or • death which can not be attributed to a documented cause and for which PE/DVT can not be ruled out (unexplained death). In the absence of objective testing, a suspected episode of DVT or PE will be considered as confirmed if it led to a change in anticoagulant treatment at therapeutic dosages for more than 48 hours. ;Secondary Objective: ;Main Objective: For the Ein | — |
Countries
Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Slovakia, Spain, Sweden, United Kingdom
Outcome results
None listed