EUCTR2006-004494-96-ITActive, not recruitingNot Applicable
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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- BAYER
- Enrollment
- 1,300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Investigators
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