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Phase 2 Study of the Safety, Tolerability and Pilot Efficacy of Oral Factor Xa Inhibitor Betrixaban Compared to Warfarin (EXPLORE-Xa)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00742859
First Posted: August 28, 2008
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Portola Pharmaceuticals
Results First Submitted: July 20, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Atrial Fibrillation
Interventions: Drug: betrixaban
Drug: Warfarin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between 31 October 2008 and 05 November 2009, 508 patients were enrolled by 35 study centers in 3 countries (USA, Canada, Germany). Patients were randomized to 1 of 4 treatment groups (1:1:1:1 allocation). The study was open-label for warfarin, while the 3 daily doses of betrixaban (40, 60, or 80 mg) were double-blinded.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
561 patients were screened for study participation. Of these patients, 508 were randomized, all of whom received at least 1 dose of study drug.

Reporting Groups
  Description
Betrixaban 40 mg Betrixaban 40 mg once daily for at least 3 months and no longer than approximately 11 months
Betrixaban 60 mg Betrixaban 60 mg once daily for at least 3 months and no longer than approximately 11 months
Betrixaban 80 mg Betrixaban 80 mg once daily for at least 3 months and no longer than approximately 11 months
Warfarin Dose-adjusted warfarin to maintain an INR of 2.0 to 3.0 with INR measured at maximum intervals of 4 weeks. Treatment duration was at least 3 months and no longer than approximately 11 months

Participant Flow:   Overall Study
    Betrixaban 40 mg   Betrixaban 60 mg   Betrixaban 80 mg   Warfarin
STARTED   127   127   127   127 
COMPLETED   116   115   116   119 
NOT COMPLETED   11   12   11   8 
Adverse Event                5                6                3                1 
Death                1                0                0                1 
Physician Decision                1                2                0                0 
Withdrawal by Subject                4                2                4                1 
Endpoint                0                1                1                2 
Amendment 2 patient off study drug >4wks                0                1                1                0 
Sponsor req visit schedule noncompliance                0                0                0                1 
Sponsor request patient out of town                0                0                1                1 
Site error                0                0                1                1 



  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.
All randomized patients who took at least 1 dose of study medication after randomization.

Reporting Groups
  Description
Betrixaban 40 mg Betrixaban 40 mg once daily for at least 3 months and no longer than approximately 11 months
Betrixaban 60 mg Betrixaban 60 mg once daily for at least 3 months and no longer than approximately 11 months
Betrixaban 80 mg Betrixaban 80 mg once daily for at least 3 months and no longer than approximately 11 months
Warfarin Dose-adjusted warfarin to maintain an INR of 2.0 to 3.0 with INR measured at maximum intervals of 4 weeks. Treatment duration was at least 3 months and no longer than approximately 11 months
Total Total of all reporting groups

Baseline Measures
   Betrixaban 40 mg   Betrixaban 60 mg   Betrixaban 80 mg   Warfarin   Total 
Overall Participants Analyzed 
[Units: Participants]
 127   127   127   127   508 
Age 
[Units: Years]
Mean (Standard Deviation)
 73.3  (8.50)   73.8  (8.35)   72.0  (7.65)   72.7  (8.75)   73.0  (8.32) 
Age, Customized 
[Units: Count of Participants]
         
<75 years   64   61   76   67   268 
>=75 years   63   66   51   60   240 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      48  37.8%      46  36.2%      38  29.9%      38  29.9%      170  33.5% 
Male      79  62.2%      81  63.8%      89  70.1%      89  70.1%      338  66.5% 


  Outcome Measures
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1.  Primary:   Exposure-adjusted Incidence Rate of Major or Clinically Relevant Non-major Bleeding Episode   [ Time Frame: A maximum of 1 year ]

2.  Secondary:   Exposure-adjusted Incidence Rate of Any Bleeding (Major, Clinically Relevant Non-major, or Minimal)   [ Time Frame: A maximum of 1 year ]


  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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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Head of Clinical Development
Organization: Portola Pharmaceuticals, Inc.
phone: 650-246-7000



Responsible Party: Portola Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00742859     History of Changes
Other Study ID Numbers: 08-015
First Submitted: August 26, 2008
First Posted: August 28, 2008
Results First Submitted: July 20, 2017
Results First Posted: September 26, 2017
Last Update Posted: October 26, 2017