Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/EUCTR2006-004494-96-AT
EUCTR2006-004494-96-ATActive, not recruitingNot Applicable

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

Bayer HealthCare AG0 sites1,300 target enrollmentStarted: April 16, 2007Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
1,300
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. Patients with confirmed symptomatic PE or DVT who have been treated for 6 or
  • •12 months with VKA (either warfarin or acenocoumarol ) or rivaroxaban
  • •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

  • •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
  • •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 CYP 3A4 inducers like rifampicin

Investigators

Similar Trials

Active, not recruiting
Not Applicable
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 - Einstein-Extension Studyong-term prevention of recurrent symptomatic venous thrombo- embolism (VTE) in patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE)MedDRA version: 6.1Level: PTClassification code 10012108
EUCTR2006-004494-96-ITBAYER1,300
Active, not recruiting
Not Applicable
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 Studyong-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embolism.
EUCTR2006-004494-96-DKBayer HealthCare AG1,300
Completed
Phase 3
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
CTRI/2007/091/000026Bayer HealthCare AG1,300
Active, not recruiting
Phase 1
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 Studyong-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embolism.
EUCTR2006-004494-96-FRBayer HealthCare AG
Active, not recruiting
Not Applicable
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 Studyong-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embolism.
EUCTR2006-004494-96-FIBayer HealthCare AG1,300