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Trial record 1 of 1 for:    VTE 11-019
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Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study) (APEX)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01583218
First Posted: April 23, 2012
Last Update Posted: September 20, 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 19, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Venous Thromboembolism (VTE)
Interventions: Drug: Betrixaban
Drug: Enoxaparin

  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
First patient was enrolled on 3/29/2012 and last patient completed the study on 1/15/2016. Patients meeting the inclusion and none of the exclusion criteria at screening were randomized 1:1 to either the betrixaban or enoxaparin treatment group.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
To maintain the blind, patients either received betrixaban capsules for 35 to 42 days and daily subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days, or received daily SQ injections of enoxaparin for 10 ± 4 days and betrixaban placebo capsules for 35 to 42 days.

Reporting Groups
  Description
Betrixaban Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days
Enoxaparin Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days

Participant Flow:   Overall Study
    Betrixaban   Enoxaparin
STARTED   3759   3754 
COMPLETED   3470   3471 
NOT COMPLETED   289   283 
Withdrawal by Subject                43                29 
Death                206                211 
Lost to Follow-up                11                17 
Adverse event or serious adverse event                3                3 
Patient /Family decision                3                0 
Cannot contact patient directly                1                2 
SOURCE DOCUMENT/COORDINATOR MISSING                0                2 
Patient did not wish to attend visits                0                1 
Patient randomized but not dosed                17                16 
Patient was assessed via phone in person                1                0 
Patient deemed ineligible after random                2                0 
Patient was early terminated from study                0                1 
Patient was randomized due to mistake                1                0 
THE SUBJECT MOVED TO ANOTHER PROVINCE                0                1 
Withdraw of consent on day of random                1                0 



  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 subjects

Reporting Groups
  Description
Betrixaban Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days
Enoxaparin Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days
Total Total of all reporting groups

Baseline Measures
   Betrixaban   Enoxaparin   Total 
Overall Participants Analyzed 
[Units: Participants]
 3759   3754   7513 
Age 
[Units: Years]
Mean (Standard Deviation)
 76.6  (8.46)   76.2  (8.31)   76.4  (8.39) 
Age, Customized 
[Units: Participants]
Count of Participants
     
<75 years   1184   1237   2421 
>=75 years   2575   2517   5092 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2054  54.6%      2034  54.2%      4088  54.4% 
Male      1705  45.4%      1720  45.8%      3425  45.6% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Modified Intent-to-Treat (mITT) Cohort 1: Percentage of Participants Experiencing the Composite Event of Symptomatic Deep Vein Thrombosis (DVT), Non-fatal Pulmonary Emboli (PE), VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3   [ Time Frame: mITT Cohort 1: Between randomization and Day 47 (max) ]

2.  Primary:   mITT Cohort 2: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3   [ Time Frame: mITT Cohort 2: Between randomization and Day 47 (max) ]

3.  Primary:   mITT: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3   [ Time Frame: mITT: Between randomization and Day 47 (max) ]

4.  Primary:   Percentage of Participants Experiencing Major Bleeding Through Seven Days After Discontinuation of All Study Medication   [ Time Frame: Between randomization and Day 49 (max) ]

5.  Secondary:   mITT Cohort 1: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3   [ Time Frame: mITT Cohort 1: Between randomization and Day 42 (max) ]

6.  Secondary:   mITT Cohort 2: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3   [ Time Frame: mITT Cohort 2: Between randomization and Day 42 (max) ]

7.  Secondary:   mITT: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3   [ Time Frame: mITT: Between randomization and Day 42 (max) ]


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Portola Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01583218     History of Changes
Other Study ID Numbers: 11-019
First Submitted: April 16, 2012
First Posted: April 23, 2012
Results First Submitted: July 19, 2017
Results First Posted: September 20, 2017
Last Update Posted: September 20, 2017