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EdoxabaN or Warfarin Therapy In Device Procedures in Patients With Non-Valvular Atrial Fibrillation (ENTICED-AF)

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: NCT02561897
Recruitment Status : Terminated (Did not meet enrolment target for phase 1)
First Posted : September 28, 2015
Results First Posted : February 10, 2020
Last Update Posted : June 30, 2020
Sponsor:
Collaborator:
Axio Research Corporation
Information provided by (Responsible Party):
Electrophysiology Research Foundation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Atrial Fibrillation
Interventions Drug: Edoxaban
Drug: Warfarin
Enrollment 5
Recruitment Details

Recruitment period 2015-2017

Recruited in hospital and medical clinic

Pre-assignment Details  
Arm/Group Title Edoxaban Warfarin
Hide Arm/Group Description

Edoxaban 30 or 60 mg

Edoxaban

Warfarin 1 -1 0 mg

Warfarin

Period Title: Overall Study
Started 2 3
Completed 2 3
Not Completed 0 0
Arm/Group Title Edoxaban Warfarin Total
Hide Arm/Group Description

Edoxaban 30 or 60 mg

Edoxaban

Warfarin 1 -1 0 mg

Warfarin

Total of all reporting groups
Overall Number of Baseline Participants 2 3 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 5 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
  50.0%
1
  33.3%
2
  40.0%
>=65 years
1
  50.0%
2
  66.7%
3
  60.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 3 participants 5 participants
60.5  (13.4) 72.0  (12.5) 69.4  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 5 participants
Female
0
   0.0%
1
  33.3%
1
  20.0%
Male
2
 100.0%
2
  66.7%
4
  80.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 5 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
2
 100.0%
3
 100.0%
5
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 2 participants 3 participants 5 participants
2
 100.0%
3
 100.0%
5
 100.0%
1.Primary Outcome
Title Major Bleeding
Hide Description Major local or systemic bleeding as defined in the protocol at 30 days after implant procedure
Time Frame Within 30 days of procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Warfarin Edoxaban
Hide Arm/Group Description:
One patient had a hematoma
No patient met primary outcome
Overall Number of Participants Analyzed 3 2
Measure Type: Count of Participants
Unit of Measure: Participants
1
  33.3%
0
   0.0%
2.Secondary Outcome
Title Thromboembolic and Cardiovascular Events
Hide Description Thrombotic events (embolism or stroke) through 6 months following the procedure in the Edoxaban and Warfarin groups and the rates of MACE events through 6 months following the procedure in the Edoxaban and Warfarin groups
Time Frame Within 6 months of procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Warfarin Edoxaban
Hide Arm/Group Description:
No patient had secondary outcome
No patient had secondary outcome
Overall Number of Participants Analyzed 3 2
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Warfarin Edoxaban
Hide Arm/Group Description To maintain therapeutic INR level 60 mg tablet once daily
All-Cause Mortality
Warfarin Edoxaban
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)      0/2 (0.00%)    
Hide Serious Adverse Events
Warfarin Edoxaban
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/3 (66.67%)      0/2 (0.00%)    
Injury, poisoning and procedural complications     
Hematoma *  1/3 (33.33%)  1 0/2 (0.00%)  0
Skin and subcutaneous tissue disorders     
Superficial wound infection * [1]  1/3 (33.33%)  1 0/2 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Superficial skin infection at three month follow up
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Warfarin Edoxaban
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/2 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sanjeev Saksena
Organization: Electrophysiology Research Foundation
Phone: 7323029990
EMail: eprf@aol.com
Layout table for additonal information
Responsible Party: Electrophysiology Research Foundation
ClinicalTrials.gov Identifier: NCT02561897    
Other Study ID Numbers: EPRF2015-01
First Submitted: September 24, 2015
First Posted: September 28, 2015
Results First Submitted: January 28, 2020
Results First Posted: February 10, 2020
Last Update Posted: June 30, 2020