Trial Outcomes & Findings for EdoxabaN or Warfarin Therapy In Device Procedures in Patients With Non-Valvular Atrial Fibrillation (NCT NCT02561897)

NCT ID: NCT02561897

Last Updated: 2020-06-30

Results Overview

Major local or systemic bleeding as defined in the protocol at 30 days after implant procedure

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 5 participants
• Primary outcome timeframe: Within 30 days of procedure
• Results posted on: 2020-06-30

Participant Flow

Recruitment period 2015-2017 Recruited in hospital and medical clinic

Participant milestones

Measure	Edoxaban Edoxaban 30 or 60 mg Edoxaban	Warfarin Warfarin 1 -1 0 mg Warfarin
Overall Study STARTED	2	3
Overall Study COMPLETED	2	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

EdoxabaN or Warfarin Therapy In Device Procedures in Patients With Non-Valvular Atrial Fibrillation

Baseline characteristics by cohort

Measure	Edoxaban n=2 Participants Edoxaban 30 or 60 mg Edoxaban	Warfarin n=3 Participants Warfarin 1 -1 0 mg Warfarin	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Age, Continuous	60.5 years STANDARD_DEVIATION 13.4 • n=93 Participants	72.0 years STANDARD_DEVIATION 12.5 • n=4 Participants	69.4 years STANDARD_DEVIATION 13 • n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants

PRIMARY outcome

Timeframe: Within 30 days of procedure

Major local or systemic bleeding as defined in the protocol at 30 days after implant procedure

Outcome measures

Measure	Warfarin n=3 Participants One patient had a hematoma	Edoxaban n=2 Participants No patient met primary outcome
Major Bleeding	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 6 months of procedure

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

Outcome measures

Measure	Warfarin n=3 Participants One patient had a hematoma	Edoxaban n=2 Participants No patient met primary outcome
Thromboembolic and Cardiovascular Events	0 Participants	0 Participants

Adverse Events

Warfarin

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Edoxaban

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Warfarin n=3 participants at risk To maintain therapeutic INR level	Edoxaban n=2 participants at risk 60 mg tablet once daily
Injury, poisoning and procedural complications Hematoma	33.3% 1/3 • Number of events 1 • 6 months	0.00% 0/2 • 6 months
Skin and subcutaneous tissue disorders Superficial wound infection	33.3% 1/3 • Number of events 1 • 6 months	0.00% 0/2 • 6 months

Other adverse events

Adverse event data not reported

Additional Information

Sanjeev Saksena

Electrophysiology Research Foundation

Phone: 7323029990

Email: eprf@aol.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place