Phase 3
N=1,197
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
Venous Thromboembolism
Bottom Line
View on ClinicalTrials.gov: NCT00439725 ↗Enrolled (actual)
1,197
Serious AEs
9.3%
Results posted
Apr 2012
Primary outcome: Primary: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment — 1.3; 7.1 Percentage of participants — p=< 0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rivaroxaban (Xarelto, BAY59-7939) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment |
1.3; 7.1 | < 0.0001 sig |
| SECONDARY Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment |
1.3; 7.2 | < 0.0001 sig |
| SECONDARY Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE, All Cause Mortality, Strokes and Myocardial Infarctions Until the Intended End of Study Treatment |
1.5; 7.4 | < 0.0001 sig |
| SECONDARY Percentage of Participants With Net Clinical Benefit as Composite of Recurrent DVT or Non-fatal or Fatal PE and Major Bleeding Events Until the Intended End of Study Treatment |
2.0; 7.1 | < 0.0001 sig |
| SECONDARY Percentage of Participants With Recurrent VTE (PE or DVT) Until the Intended End of Study Treatment |
1.2; 7.1 | — |
| SECONDARY Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment |
0.8; 5.2 | — |
| SECONDARY Percentage of Participants With Major Bleeding |
0.7; 0.0; 0.7; 0.2 | 0.1121 |
| SECONDARY Percentage of Participants With Clinically Relevant Bleeding |
6.0; 1.2; 6.0; 1.9 | < 0.0001 sig |
| SECONDARY Percentage of Participants With All Death |
0.2; 0.2; 0.2; 0.3 | — |
| SECONDARY Percentage of Participants With Other Vascular Events |
0.5; 0.7; 0.8; 0.7 | — |
Summary
This is a multicenter, randomized, double-blind, placebo-controlled, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT (deep vein thrombosis) or PE (pulmonary embolism) who completed 6 or 12 months of treatment with rivaroxaban or VKA (vitamin K antagonist) are eligible for this trial (Einstein-Extension study).
Eligibility Criteria
Inclusion Criteria
- Patients with confirmed symptomatic PE or DVT who have been treated for 6 or 12 months with VKA or rivaroxaban
Exclusion Criteria
- Legal lower age limitations (country specific)
- Indication for VKA other than DVT and/or PE
- Patients in whom anticoagulant treatment for their index PE or DVT should be continued
- Childbearing potential without proper contraceptive measures, pregnancy or breast feeding. Proper contraceptive measures are defined as a method of contraception with a failure rate < 1 % during the course of the study (including the observational period). These methods of contraception according to the note for guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP [Committee for Proprietary Medicinal Products]/ICH [International Conference on Harmonization]/286/95, modification) include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence and vasectomy
Data sourced from ClinicalTrials.gov (NCT00439725). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.