Oral direct factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep-vein thrombosis or pulmonary embolism.
- Conditions
- venous thromboembolism10014523
- Registration Number
- NL-OMON33723
- Lead Sponsor
- Bayer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 300
a. For Einstein-DVT:confirmed acute symptomatic proximal DVT without symptomatic PE, or
b. For Einstein-PE:confirmed acute symptomatic PE with or without symptomatic DVT
2. Written informed consent
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 < 30 ml/min
7. Significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT > 3 x ULN
8. Bacterial endocarditis
9. Life expectancy <3 months
10. Active bleeding or high risk for bleeding contraindicating treatment with
enoxaparin or VKA
11. Systolic blood pressure >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 enoxaparin, warfarin, or acenocoumarol
14. Concomitant use of strong CYP3A4 inhibitors (e.g., HIV protease inhibitors, systemic ketoconazole) or strong CYP 3A4 inducers like rifampicin.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy outcome is symptomatic recurrent VTE, i.e., the composite<br /><br>of (recurrent) DVT or fatal or non-fatal PE. The primary efficacy analysis is<br /><br>based on the time to the first symptomatic recurrent VTE event during the 3-,<br /><br>6-, and 12-month study treatment periods. The principal safety outcome is the<br /><br>combination of major and clinically relevant non-major bleeding. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Other safety outcomes include all deaths and other vascular events.</p><br>