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Edoxaban in Peripheral Arterial Disease (ePAD)

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.
ClinicalTrials.gov Identifier: NCT01802775
Recruitment Status : Completed
First Posted : March 1, 2013
Results First Posted : January 12, 2018
Last Update Posted : January 12, 2018
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Peripheral Arterial Disease
Interventions: Drug: edoxaban
Drug: Clopidogrel
Drug: Aspirin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 275 subjects were screened, of these 203 subjects were randomized into the study, with 101 subjects in the edoxaban group and 102 subjects in the clopidogrel group.

Reporting Groups
  Description
Clopidogrel Open-label clopidogrel with aspirin
Edoxaban Open-label edoxaban with aspirin

Participant Flow:   Overall Study
    Clopidogrel   Edoxaban
STARTED   102   101 
Received Drug (Safety Analysis Set)   101   100 
COMPLETED   96   89 
NOT COMPLETED   6   12 
Death                0                3 
Reason not provided                0                1 
Physician Decision                1                0 
Adverse Event                1                1 
Withdrawal by Subject                3                5 
Lost to Follow-up                1                2 



  Baseline Characteristics

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.
Intention to treat - all participants enrolled in the trial

Reporting Groups
  Description
Clopidogrel Open-label clopidogrel with aspirin
Edoxaban Open-label edoxaban with aspirin
Total Total of all reporting groups

Baseline Measures
   Clopidogrel   Edoxaban   Total 
Overall Participants Analyzed 
[Units: Participants]
 102   101   203 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.7  (8.55)   68  (10.36)   67.4  (9.49) 
Age, Customized 
[Units: Participants]
Count of Participants
     
Adults 18-64 years of age   33   30   63 
From 65 to 84 years of age   68   65   133 
85 years of age and over   1   6   7 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      24  23.5%      34  33.7%      58  28.6% 
Male      78  76.5%      67  66.3%      145  71.4% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
Austria   13   15   28 
Netherlands   5   8   13 
Belgium   6   9   15 
United States   47   42   89 
Israel   7   5   12 
Switzerland   13   12   25 
Germany   11   10   21 


  Outcome Measures

1.  Primary:   Percentage of Participants With Clinically Relevant Bleeding During Treatment   [ Time Frame: at 3 months ]

2.  Primary:   Percentage of Participants With First Re-stenosis / Re-occlusion   [ Time Frame: within 6 months ]

3.  Secondary:   Percentage of Participants With Major, Clinically Relevant Non-major (CRNM), and Minor Bleeding During Treatment   [ Time Frame: within 3 months ]

4.  Secondary:   Safety Assessments   [ Time Frame: within 6 months ]

5.  Secondary:   Number of Adjudicated Major Adverse Cardiovascular Events During the Overall Study Period   [ Time Frame: within 6 months ]

6.  Secondary:   Number of Participants With Amputations   [ Time Frame: within 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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: Clinical Trial Information
Organization: Daiichi Sankyo Development Inc.
phone: +44 1753482800
e-mail: info@dsd-eu.com


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

Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT01802775     History of Changes
Other Study ID Numbers: DU176b-E-U210
2012-003009-88 ( EudraCT Number )
First Submitted: February 25, 2013
First Posted: March 1, 2013
Results First Submitted: December 11, 2017
Results First Posted: January 12, 2018
Last Update Posted: January 12, 2018