Phase 3
N=4,833
Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism - The EINSTEIN PE Study
Pulmonary Embolism
Bottom Line
View on ClinicalTrials.gov: NCT00439777 ↗Enrolled (actual)
4,833
Serious AEs
20.7%
Results posted
Jan 2013
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 — 2.1; 1.8 Percentage of participants — p=0.0026
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rivaroxaban (Xarelto, BAY59-7939) (Drug); Enoxaparin overlapping with and followed by VKA (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Sep 2011
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 |
2.1; 1.8 | 0.0026 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 |
4.0; 3.4 | 0.33 |
| SECONDARY Percentage of Participants With an Event for Net Clinical Benefit 1 Until the Intended End of Study Treatment |
3.4; 4.0 | 0.275 |
| SECONDARY Percentage of Participants With Recurrent PE Until the Intended End of Study Treatment |
1.4; 1.2 | 0.55 |
| SECONDARY Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment |
0.7; 0.8 | 0.85 |
| SECONDARY Percentage of Participants With Clinically Relevant Bleeding, Treatment-emergent (Time Window: Until 2 Days After Last Dose) |
10.3; 11.4 | 0.23 |
| SECONDARY Percentage of Participants With All Deaths |
2.6; 2.1; 1.2; 0.8; 1.5; 1.1 | — |
| SECONDARY Percentage of Participants With Other Vascular Events, On-treatment (Time Window: Until 1 Day After Last Dose) |
1.5; 1.5 | — |
Summary
This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with confirmed acute symptomatic pulmonary embolism (PE) with or without symptomatic Deep-Vein Thrombosis (DVT) (Einstein-PE).
Eligibility Criteria
Inclusion Criteria
- Confirmed acute symptomatic proximal PE with or without symptomatic DVT
Exclusion Criteria
- Legal lower age limitations (country specific)
- Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE
- Other indication for VKA than DVT and/or PE
- The pre-randomization anti-coagulant treatment (Criteria # 4) has been prolonged from 36 hours to a maximum of 48 hours.
Data sourced from ClinicalTrials.gov (NCT00439777). 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.