OT AVAILABLE

Not Applicable

• Registration Number: PER-027-10
• Lead Sponsor: BAYER HEALTHCARE AG,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-14
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified