Trial Outcomes & Findings for Apixaban Evaluation of Interrupted Or Uninterrupted Anticoagulation for Ablation of Atrial Fibrillation (NCT NCT02608099)

Last Updated: 2020-03-17

Results Overview

Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

300 participants

Primary outcome timeframe

Randomization to 1 month post catheter ablation

Results posted on

2020-03-17

Participant Flow

Participant milestones

Participant milestones
Measure	Interrupted Apixaban Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Interrupted apixaban: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.	Uninterrupted Apixaban Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Uninterrupted apixaban: Intervention description: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.
Overall Study STARTED	148	152
Overall Study Safety	149	151
Overall Study COMPLETED	145	150
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Interrupted Apixaban Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Interrupted apixaban: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.	Uninterrupted Apixaban Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Uninterrupted apixaban: Intervention description: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.
Overall Study Ablation procedure not initiated	3	2

Baseline Characteristics

A total of 280 patients were evaluated for ethnicity measurement.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Interrupted Apixaban n=145 Participants Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Interrupted apixaban: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.	Uninterrupted Apixaban n=150 Participants Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Uninterrupted apixaban: Intervention description: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.	Total n=295 Participants Total of all reporting groups
Age, Continuous	64.3 Years STANDARD_DEVIATION 10.3 • n=145 Participants	62.8 Years STANDARD_DEVIATION 9.9 • n=150 Participants	63.5 Years STANDARD_DEVIATION 10.1 • n=295 Participants
Sex: Female, Male Female	48 Participants n=145 Participants	49 Participants n=150 Participants	97 Participants n=295 Participants
Sex: Female, Male Male	97 Participants n=145 Participants	101 Participants n=150 Participants	198 Participants n=295 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=135 Participants • A total of 280 patients were evaluated for ethnicity measurement.	2 Participants n=145 Participants • A total of 280 patients were evaluated for ethnicity measurement.	3 Participants n=280 Participants • A total of 280 patients were evaluated for ethnicity measurement.
Ethnicity (NIH/OMB) Not Hispanic or Latino	134 Participants n=135 Participants • A total of 280 patients were evaluated for ethnicity measurement.	143 Participants n=145 Participants • A total of 280 patients were evaluated for ethnicity measurement.	277 Participants n=280 Participants • A total of 280 patients were evaluated for ethnicity measurement.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=135 Participants • A total of 280 patients were evaluated for ethnicity measurement.	0 Participants n=145 Participants • A total of 280 patients were evaluated for ethnicity measurement.	0 Participants n=280 Participants • A total of 280 patients were evaluated for ethnicity measurement.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=139 Participants • A total of 283 patients were evaluated for race measurement.	1 Participants n=144 Participants • A total of 283 patients were evaluated for race measurement.	1 Participants n=283 Participants • A total of 283 patients were evaluated for race measurement.
Race (NIH/OMB) Asian	2 Participants n=139 Participants • A total of 283 patients were evaluated for race measurement.	0 Participants n=144 Participants • A total of 283 patients were evaluated for race measurement.	2 Participants n=283 Participants • A total of 283 patients were evaluated for race measurement.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=139 Participants • A total of 283 patients were evaluated for race measurement.	0 Participants n=144 Participants • A total of 283 patients were evaluated for race measurement.	0 Participants n=283 Participants • A total of 283 patients were evaluated for race measurement.
Race (NIH/OMB) Black or African American	4 Participants n=139 Participants • A total of 283 patients were evaluated for race measurement.	2 Participants n=144 Participants • A total of 283 patients were evaluated for race measurement.	6 Participants n=283 Participants • A total of 283 patients were evaluated for race measurement.
Race (NIH/OMB) White	133 Participants n=139 Participants • A total of 283 patients were evaluated for race measurement.	141 Participants n=144 Participants • A total of 283 patients were evaluated for race measurement.	274 Participants n=283 Participants • A total of 283 patients were evaluated for race measurement.
Race (NIH/OMB) More than one race	0 Participants n=139 Participants • A total of 283 patients were evaluated for race measurement.	0 Participants n=144 Participants • A total of 283 patients were evaluated for race measurement.	0 Participants n=283 Participants • A total of 283 patients were evaluated for race measurement.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=139 Participants • A total of 283 patients were evaluated for race measurement.	0 Participants n=144 Participants • A total of 283 patients were evaluated for race measurement.	0 Participants n=283 Participants • A total of 283 patients were evaluated for race measurement.
Body Mass Index	30.46 kg/m2 STANDARD_DEVIATION 5.607 • n=145 Participants	30.58 kg/m2 STANDARD_DEVIATION 6.441 • n=150 Participants	30.52 kg/m2 STANDARD_DEVIATION 6.036 • n=295 Participants

PRIMARY outcome

Timeframe: Randomization to 1 month post catheter ablation

Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher.

Outcome measures

Outcome measures
Measure	Interrupted Apixaban n=145 Participants Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Interrupted apixaban: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.	Uninterrupted Apixaban n=150 Participants Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Uninterrupted apixaban: Intervention description: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.
Number of Patients With Clinically-Significant Bleeding	14 Participants	17 Participants

PRIMARY outcome

Timeframe: Randomization to 1 month post catheter ablation

Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events.

Outcome measures

Outcome measures
Measure	Interrupted Apixaban n=145 Participants Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Interrupted apixaban: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.	Uninterrupted Apixaban n=150 Participants Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Uninterrupted apixaban: Intervention description: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.
Number of Patients With Thrombotic Events	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Randomization to 1 month post catheter ablation

Major bleeding was defined as bleeding meeting BARC criteria type 3 or higher. Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events.

Outcome measures

Outcome measures
Measure	Interrupted Apixaban n=145 Participants Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Interrupted apixaban: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.	Uninterrupted Apixaban n=150 Participants Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Uninterrupted apixaban: Intervention description: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.
Number of Patients With Composite of Major Bleeding and Thrombotic Events	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Randomization to 1 month post catheter ablation

Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events. Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher.

Outcome measures

Outcome measures
Measure	Interrupted Apixaban n=145 Participants Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Interrupted apixaban: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.	Uninterrupted Apixaban n=150 Participants Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Uninterrupted apixaban: Intervention description: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.
Number of Patients With Composite of Clinically Significant Bleeding and Thrombotic Events	14 Participants	17 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Enrollment to 1 month post catheter ablation

Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher.

Outcome measures

Outcome measures
Measure	Interrupted Apixaban n=145 Participants Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Interrupted apixaban: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.	Uninterrupted Apixaban n=150 Participants Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Uninterrupted apixaban: Intervention description: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.
Number of Patients With Clinically-Significant Bleeding	17 Participants	17 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Randomization to 1 month post catheter ablation

Major bleeding was defined as bleeding meeting BARC criteria type 3 or higher.

Outcome measures

Outcome measures
Measure	Interrupted Apixaban n=145 Participants Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Interrupted apixaban: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.	Uninterrupted Apixaban n=150 Participants Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Uninterrupted apixaban: Intervention description: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.
Number of Patients With Major Bleeding	3 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Enrollment to 1 month post catheter ablation

Major bleeding was defined as bleeding meeting BARC criteria type 3 or higher.

Outcome measures

Outcome measures
Measure	Interrupted Apixaban n=145 Participants Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Interrupted apixaban: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.	Uninterrupted Apixaban n=150 Participants Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Uninterrupted apixaban: Intervention description: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.
Number of Patients With Major Bleeding	3 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Enrollment to 1 month post catheter ablation

Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events.

Outcome measures

Outcome measures
Measure	Interrupted Apixaban n=145 Participants Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Interrupted apixaban: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.	Uninterrupted Apixaban n=150 Participants Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Uninterrupted apixaban: Intervention description: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.
Number of Patients With Thrombotic Events	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Enrollment to 1 month post catheter ablation

Outcome measures

Outcome measures
Measure	Interrupted Apixaban n=145 Participants Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Interrupted apixaban: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.	Uninterrupted Apixaban n=150 Participants Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Uninterrupted apixaban: Intervention description: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.
Number of Patients With Composite of Clinically Significant Bleeding and Thrombotic Events	14 Participants	17 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Enrollment to 1 month post catheter ablation

Thrombotic events are defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events. Major bleeding is defined as bleeding meeting BARC criteria type 3 or higher.

Outcome measures

Outcome measures
Measure	Interrupted Apixaban n=145 Participants Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Interrupted apixaban: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.	Uninterrupted Apixaban n=150 Participants Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Uninterrupted apixaban: Intervention description: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.
Number of Patients With Composite of Major Bleeding and Thrombotic Events	3 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Enrollment to 1 month post catheter ablation

Number of Patients who had TIAs or non-hemorrhagic strokes.

Outcome measures

Outcome measures
Measure	Interrupted Apixaban n=145 Participants Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Interrupted apixaban: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.	Uninterrupted Apixaban n=150 Participants Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Uninterrupted apixaban: Intervention description: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.
Number of Patients With TIAs or Non-Hemorrhagic Strokes	1 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Randomization to 1 month post catheter ablation

This measurement includes TIAs or non-hemorrhagic strokes.

Outcome measures

Outcome measures
Measure	Interrupted Apixaban n=145 Participants Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Interrupted apixaban: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.	Uninterrupted Apixaban n=150 Participants Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Uninterrupted apixaban: Intervention description: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.
Number of Patients With TIAs or Non-Hemorrhagic Strokes	1 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Enrollment to 1 month post catheter ablation

Death is included in this measurement.

Outcome measures

Outcome measures
Measure	Interrupted Apixaban n=145 Participants Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Interrupted apixaban: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.	Uninterrupted Apixaban n=150 Participants Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Uninterrupted apixaban: Intervention description: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.
Number of Patients With Death	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Enrollment to 1 month post catheter ablation

Cardiovascular death is included in this measurement.

Outcome measures

Outcome measures
Measure	Interrupted Apixaban n=145 Participants Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Interrupted apixaban: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.	Uninterrupted Apixaban n=150 Participants Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Uninterrupted apixaban: Intervention description: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.
Number of Patients With Cardiovascular Death	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Randomization to 1 month post catheter ablation

Death is included in this measurement.

Outcome measures

Outcome measures
Measure	Interrupted Apixaban n=145 Participants Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Interrupted apixaban: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.	Uninterrupted Apixaban n=150 Participants Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Uninterrupted apixaban: Intervention description: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.
Number of Patients With Death	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Randomization to 1 month post catheter ablation

Cardiovascular death is included in this measurement.

Outcome measures

Outcome measures
Measure	Interrupted Apixaban n=145 Participants Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Interrupted apixaban: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.	Uninterrupted Apixaban n=150 Participants Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Uninterrupted apixaban: Intervention description: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.
Number of Patients With Cardiovascular Death	0 Participants	0 Participants

Adverse Events

Interrupted Apixaban

Serious events: 14 serious events

Other events: 72 other events

Deaths: 0 deaths

Uninterrupted Apixaban

Serious events: 15 serious events

Other events: 75 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Director of Trial Design and Development

Baim Institute for Clinical Research

Phone: 617-307-5200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Interrupted Apixaban n=149 participants at risk Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Interrupted apixaban: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. A total of 149 patients were included in the "Interrupted Apixaban" arm from the safety population (patients were analyzed under the actual treatment received).	Uninterrupted Apixaban n=151 participants at risk Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Uninterrupted apixaban: Intervention description: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. A total of 151 patients were included in the "Uninterrupted Apixaban" arm from the safety population (patients were analyzed under the actual treatment received).
Cardiac disorders Arrhythmia Supraventricular	1.3% 2/149 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.	0.66% 1/151 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.
Eye disorders Blindness Transient	0.00% 0/149 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.	0.66% 1/151 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.00% 0/149 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.	0.66% 1/151 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.
General disorders Catheter Site Haemorrhage	0.67% 1/149 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.	0.00% 0/151 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.
Infections and infestations Pneumonia Mycoplasmal	0.67% 1/149 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.	0.00% 0/151 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.
Injury, poisoning and procedural complications Vascular Pseudoaneurysm	0.67% 1/149 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.	0.66% 1/151 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.
Metabolism and nutrition disorders Fluid Overload	0.67% 1/149 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.	0.00% 0/151 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.
Musculoskeletal and connective tissue disorders Fistula	0.00% 0/149 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.	0.66% 1/151 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Adenocarcinoma	0.00% 0/149 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.	0.66% 1/151 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.
Nervous system disorders Migraine	0.00% 0/149 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.	0.66% 1/151 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.
Renal and urinary disorders Haematuria	0.00% 0/149 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.	0.66% 1/151 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.67% 1/149 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.	0.00% 0/151 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.
Vascular disorders Hypotension	0.00% 0/149 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.	1.3% 2/151 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.
Cardiac disorders Atrial Fibrillation	1.3% 2/149 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.	2.0% 3/151 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.
Cardiac disorders Atrial Flutter	1.3% 2/149 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.	0.66% 1/151 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.
Cardiac disorders Cardiac Failure Congestive	0.67% 1/149 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.	0.00% 0/151 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.
Cardiac disorders Cardiac Perforation	0.00% 0/149 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.	0.66% 1/151 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.
Cardiac disorders Cardiogenic Shock	0.00% 0/149 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.	0.66% 1/151 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.
Cardiac disorders Sinus Arrest	0.67% 1/149 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.	0.00% 0/151 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.
General disorders Catheter Site Pain	0.67% 1/149 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.	0.00% 0/151 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.
Infections and infestations Sepsis	0.00% 0/149 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.	0.66% 1/151 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.
Infections and infestations Urinary Tract Infection	0.00% 0/149 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.	1.3% 2/151 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.
Metabolism and nutrition disorders Hypervolaemia	0.67% 1/149 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.	0.00% 0/151 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.
Nervous system disorders Presyncope	0.00% 0/149 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.	0.66% 1/151 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.
Renal and urinary disorders Urinary Retention	0.67% 1/149 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.	0.00% 0/151 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	0.67% 1/149 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.	0.00% 0/151 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.
Respiratory, thoracic and mediastinal disorders Pharyngeal Haemorrhage	0.00% 0/149 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.	0.66% 1/151 • 1 Month Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.