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

• Conditions: Treatment and secondary prevention of venous thromboembolism in patients with acute symptomatic deep- vein thrombosis or pulmonary embolism

• Registration Number: EUCTR2006-004495-13-IE
• Lead Sponsor: Bayer Healthcare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-21
• Last Update Posted: 11 November 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 7465

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 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 clinical trial of medicinal product
• Study Design: Not specified