Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism - The EINSTEIN PE Study

This study has been completed.
Sponsor:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00439777
First received: February 23, 2007
Last updated: January 25, 2014
Last verified: January 2014
Results First Received: November 22, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pulmonary Embolism
Interventions: Drug: Rivaroxaban (Xarelto, BAY59-7939)
Drug: Enoxaparin overlapping with and followed by VKA

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Rivaroxaban (Xarelto, BAY59-7939) Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
Enoxaparin/VKA Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
Total Total of all reporting groups

Baseline Measures
    Rivaroxaban (Xarelto, BAY59-7939)     Enoxaparin/VKA     Total  
Number of Participants  
[units: participants]
  2419     2413     4832  
Age [1]
[units: Years]
Mean ± Standard Deviation
  57.9  ± 17.3     57.5  ± 17.2     57.7  ± 17.3  
Age, Customized [1]
[units: Participants]
     
18 - < 40 years     410     432     842  
40 - < 60 years     794     779     1573  
60 - < 75 years     740     754     1494  
≥ 75 years     475     448     923  
Gender [1]
[units: Participants]
     
Female     1309     1247     2556  
Male     1110     1166     2276  
[1] Intention-to-treat (ITT) population



  Outcome Measures
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1.  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   [ Time Frame: 3-, 6-, or 12-month study treatment period ]

2.  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   [ Time Frame: 3-, 6-, or 12-month study treatment period ]

3.  Secondary:   Percentage of Participants With an Event for Net Clinical Benefit 1 Until the Intended End of Study Treatment   [ Time Frame: 3-, 6-, or 12-month study treatment period ]

4.  Secondary:   Percentage of Participants With Recurrent PE Until the Intended End of Study Treatment   [ Time Frame: 3-, 6- or 12-month study treatment period ]

5.  Secondary:   Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment   [ Time Frame: 3-, 6- or 12-month study treatment period ]

6.  Secondary:   Percentage of Participants With Clinically Relevant Bleeding, Treatment-emergent (Time Window: Until 2 Days After Last Dose)   [ Time Frame: 3-, 6- or 12-month study treatment period ]

7.  Secondary:   Percentage of Participants With All Deaths   [ Time Frame: 3-, 6- or 12-month study treatment period ]

8.  Secondary:   Percentage of Participants With Other Vascular Events, On-treatment (Time Window: Until 1 Day After Last Dose)   [ Time Frame: 3-, 6- or 12-month study treatment period ]

9.  Other Pre-specified:   Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment   [ Time Frame: 3-, 6- or 12-month study treatment period ]

10.  Other Pre-specified:   Percentage of Participants With Symptomatic Recurrent VTE (i.e. the Composite of Recurrent DVT or Fatal or Non-fatal PE) During Observational Period   [ Time Frame: Up to 30 days after the last intake of study medication ]

11.  Other Pre-specified:   Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality During Observational Period   [ Time Frame: Up to 30 days after the last intake of study medication ]

12.  Other Pre-specified:   Percentage of Participants With an Event for Net Clinical Benefit 1 During Observational Period   [ Time Frame: Up to 30 days after the last intake of study medication ]

13.  Other Pre-specified:   Percentage of Participants With Recurrent DVT During Observational Period   [ Time Frame: Up to 30 days after the last intake of study medication ]

14.  Other Pre-specified:   Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period   [ Time Frame: Up to 30 days after the last intake of study medication ]

15.  Post-Hoc:   Percentage of Participants With an Event for Net Clinical Benefit 2 Until the Intended End of Study Treatment   [ Time Frame: 3-, 6- or 12-month study treatment period ]

16.  Post-Hoc:   Percentage of Participants With an Event for Net Clinical Benefit 2 During Observational Period   [ Time Frame: Up to 30 days after the last intake of study medication ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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