Once-daily oral direct factor Xa rivaroxaban in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embolism. The Einstein-Extension study.

Phase 3

• Conditions: venous thromboembolism; 10014523

• Registration Number: NL-OMON31783
• Lead Sponsor: Bayer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

Patients with confirmed symptomatic PE or DVT who have been treated for 6 to 14 months with VKA (either warfarin or acenocoumarol ) outside of the Einstein VTE treatment program (study 11702) or who have been treated for 6 or 12 months with VKA or rivaroxaban in the 11702 study.

Exclusion Criteria

1. Legal lower age limitations (country specific)
2. Indication for VKA other than DVT and/or PE
3. Patients in whom anticoagulant treatment for their index PE or DVT should be continued
4. Significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT > 3 x ULN
5. Creatinine clearance < 30 ml/min
6. Bacterial endocarditis
7. Active bleeding or high risk for bleeding.
8. Systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg
9. Childbearing potential without proper contraceptive measures, pregnancy or breast feeding
10. Participation in another pharmacotherapeutic study other than the Einstein VTE program (rivaroxaban/11702) within the prior 30 days
11. Life expectancy <3 months
12. Concomitant use of strong CYP3A4 inhibitors (e.g., HIV protease inhibitors, systemic ketoconazole) or strong CYP3A4 inducers like rifampicin

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy outcome is symptomatic recurrent VTE, i.e., the composite<br /><br>of recurrent DVT or fatal or non-fatal PE. The primary efficacy analysis is<br /><br>based on the time to the first symptomatic recurrent VTE event.<br /><br>The principal safety outcome is major bleeding.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Other safety outcomes include all deaths and other vascular events</p><br>