Oral direct factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep-vein thrombosis or pulmonary embolism. - ''Einstein''

• Conditions: Treatment and secondary prevention of venous thromboembolism in patients with acute symptomatic deep-vein thrombosis or pulmonary embolism.; MedDRA version: 6.1Level: PTClassification code 10043566

• Registration Number: EUCTR2006-004495-13-IT
• Lead Sponsor: BAYER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-02
• Last Update Posted: 28 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 6260

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 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

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 36 hours pre-randomization treatment with therapeutic dosages of (LMW)Heparin/fondaparinux 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 ketoconazole)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified