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AStudy To Evaluate Safety And Eficacy Of Apixaban In Japanese Acute Deep Vein Thrombosis (DVT) And Pulmonary Embolism (PE) Patients

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01780987
First received: January 29, 2013
Last updated: May 16, 2016
Last verified: May 2016
Results First Received: January 20, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Deep Vein Thrombosis
Pulmonary Embolism
Interventions: Drug: Apixaban
Drug: Unfractionated Heparin (UFH)
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Apixaban Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
Unfractionated Heparin (UFH)/Warfarin UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.

Participant Flow:   Overall Study
    Apixaban   Unfractionated Heparin (UFH)/Warfarin
STARTED   40   40 [1] 
COMPLETED   37   34 
NOT COMPLETED   3   6 
Adverse Event                0                4 
Withdrawal by Subject                2                0 
Request of Changing Hospital                0                1 
Changing Residence                1                0 
Not Receiving any Study Medication                0                1 
[1] Including one participant who withdrew from the study prior to receiving any study medication.



  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 participants including one participant who was assigned to the UFH/Warfarin group and withdrew from the study prior to receiving any study medication.

Reporting Groups
  Description
Apixaban Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
Unfractionated Heparin (UFH)/Warfarin UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
Total Total of all reporting groups

Baseline Measures
   Apixaban   Unfractionated Heparin (UFH)/Warfarin   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   40   80 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.3  (13.40)   66.1  (17.72)   65.2  (15.64) 
Gender 
[Units: Participants]
     
Female   18   23   41 
Male   22   17   39 
Primary Diagnosis, Deep Venous Thrombosis (DVT)/Pulmonary Embolism (PE) 
[Units: Participants]
     
DVT   22   23   45 
PE   18   17   35 


  Outcome Measures
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1.  Primary:   Number of Participants With Major Bleeding Events [Per International Society on Thrombosis and Homeostasis (ISTH) Definition] or Clinically Relevant Non-major (CRNM) Bleeding Events Adjudicated by Clinical Event Committee During the Treatment Period   [ Time Frame: Baseline to Week 24 ]

2.  Secondary:   Number of Participants With Adjudicated Recurrent Symptomatic Venous Thromboembolism (VTE) [Nonfatal Deep Venous Thrombosis (DVT) or Nonfatal Pulmonary Embolism (PE)] or VTE-Related Death During the Intended Treatment Period   [ Time Frame: Baseline to Week 24 ]

3.  Secondary:   Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Proximal Deep Venous Thrombosis (DVT)   [ Time Frame: Baseline to Week 24 ]

4.  Secondary:   Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Pulmonary Embolism (PE)   [ Time Frame: Baseline to Week 24 ]

5.  Secondary:   Number of Participants With Adjudicated Major Bleeding Events [Per International Society on Thrombosis and Homeostasis (ISTH) Definition]During the Treatment Period   [ Time Frame: Baseline to Week 24 ]

6.  Secondary:   Number of Participants With Adjudicated All Bleeding Events During the Treatment Periods   [ Time Frame: Baseline to Week 24 ]


  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: Pfizer Clinical Trials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_inquiries@pfizer.com



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01780987     History of Changes
Other Study ID Numbers: B0661024
CV185160 ( Other Identifier: BMS )
Study First Received: January 29, 2013
Results First Received: January 20, 2016
Last Updated: May 16, 2016
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency