EUCTR2006-004495-13-NLActive, not recruitingNot Applicable
Oral direct factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep-vein thrombosis or pulmonary embolism.
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Bayer Healthcare AG
- Enrollment
- 7,400
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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 anti-coagulant 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 warfarin,
- •acenocoumarol, or enoxaparin
- •14. Concomitant use of strong CYP3A4 inhibitors (e.g., HIV protease inhibitors, systemic ketokonazole) or strong CYP 3A4 inducers like rifampicin
Investigators
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