PER-027-10Completed未知
RIVAROXABAN ORAL, DIRECT INHIBITOR OF XA ORAL FACTOR IN PATIENTS WITH DEEP VENOUS THROMBOSIS OR LUNG EMBOLIS SYMPTOMATIC ACIDS”
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- BAYER HEALTHCARE AG,
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 100 (—)
Inclusion Criteria
- •1. For the Einstein-DVT evaluation: Confirmed acute symptomatic PD without symptomatic PD or For Einstein-EP assessment: Acute symptomatic PD confirmed with or without symptomatic DVT. 2. FCI in writing.
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 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 warfarin, Acenocoumarol, or enoxaparin.
- •14. Concomitant use of strong CYP3A4 inhibitors (e.g., HIV protease inhibitors, systemic ketokonazole) or strong CYP3A4 inducers like rifampicin.
Investigators
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