Once-daily oral direct factor Xa inhibitor rivaroxaban in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embolism. The Einstein-Extension study - Einstein-Extension Study
- Conditions
- ong-term prevention of recurrent symptomatic venous thrombo- embolism (VTE) in patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE)MedDRA version: 6.1Level: PTClassification code 10012108
- Registration Number
- EUCTR2006-004494-96-IT
- Lead Sponsor
- BAYER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1300
1. Patients with confirmed symptomatic PE or DVT who have been treated for 6 or 12 months with VKA (either warfarin or acenocoumarol ) or rivaroxaban 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
Legal lower age limitations (country specific) 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. Significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT > 3 x ULN 5. Creatinine clearance < 30 ml/min 6. Bacterial endocarditis 7. Active bleeding or high risk for bleeding. 8. Systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg 9. Childbearing potential without proper contraceptive measures, pregnancy or breast feeding 10. Participation in another pharmacotherapeutic study other than the Einstein VTE program (rivaroxaban/11702) within the prior 30 days 11. Life expectancy <3 months 12. Concomitant use of strong CYP3A4 inhibitors (e.g., HIV protease inhibitors, systemic ketoconazole)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary efficacy objective is to evaluate whether rivaroxaban is superior to placebo in the long-term prevention of recurrent symptomatic venous thrombo- embolism (VTE) in patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) who completed 6 or 12 months of treatment with vitamin K antagonist (VKA) or rivaroxaban.;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
- Secondary Outcome Measures
Name Time Method