Once-daily oral direct factor Xa 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. - The Einstein-Extension Study
- Conditions
- ong-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embolism.
- Registration Number
- EUCTR2006-004494-96-GB
- Lead Sponsor
- Bayer HealthCare AG
- 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 to
14 months with VKA (either warfarin or acenocoumarol ) outside of the Einstein VTE treatment program (study 11702), or who have been treated for 6 or 12 months with VKA or rivaroxaban in the 11702 study.
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
1. 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) or strong CYP3A4 inducers like rifampicin
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<br>placebo in the long-term prevention of recurrent symptomatic venous thromboembolism (VTE) in patients with symptomatic deep-vein thrombosis (DVT) or<br>pulmonary embolism (PE) who completed 6 to 14 months of treatment with vitamin<br>K antagonist (VKA) outside of the Einstein VTE treatment program (study 11702) or who completed 6 or 12 months with VKA or rivaroxaban in the 11702 study.;Secondary Objective: ;Primary end point(s): The primary efficacy outcome is symptomatic recurrent VTE, i.e., the composite of<br>recurrent DVT or fatal or non-fatal PE<br>
- Secondary Outcome Measures
Name Time Method