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Once-daily oral direct factor Xa inhibitor 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. - The Einstein-Extension Study

Once-daily oral direct factor Xa inhibitor 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. - The Einstein-Extension Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-004494-96-DE
Enrollment
1300
Registered
2007-02-21
Start date
2007-05-22
Completion date
Unknown
Last updated
2012-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embolism.

Interventions

Product Name: Rivaroxaban Product Code: BAY 59-7939 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Rivaroxaban CAS Number: 366789-02-8 Current Sponsor code: BAY 59-7939 Concentration uni

Sponsors

Bayer HealthCare AG
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 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. 2. 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

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 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 CYP 3A4 inducers like rifampicin

Design outcomes

Primary

MeasureTime frame
Main Objective: The primary efficacy objective is to evaluate whether rivaroxaban is superior to placebo in the long-term prevention of recurrent symptomatic venous thromboembolism (VTE) in patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) who completed 6 to 14 months of treatment with vitamin K antagonist (VKA) outside of the Einstein VTE treatment program (study 11702) or who completed 6 or 12 months with VKA or rivaroxaban in the 11702 study.;Secondary Objective: ;Primary end point(s): The primary efficacy outcome is symptomatic recurrent VTE, i.e., the composite of recurrent DVT or fatal or non-fatal PE—

Countries

Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Spain, Sweden, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026