Trial Outcomes & Findings for Rhythm Evaluation for AntiCoagulaTion With COntinuous Monitoring (NCT NCT01706146)

NCT ID: NCT01706146

Last Updated: 2016-03-23

Results Overview

Assess subject anticoagulant utilization and number of days on anticoagulation

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 59 participants
• Primary outcome timeframe: up to 12 months
• Results posted on: 2016-03-23

Participant Flow

Participant milestones

Measure	Non-Coumadin Oral Anticoagulant Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device. Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.
Overall Study STARTED	59
Overall Study COMPLETED	53
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Non-Coumadin Oral Anticoagulant Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device. Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.
Overall Study Withdrawal by Subject	1
Overall Study Adverse Event	3
Overall Study Developed AF and need for antiplatelets	2

Baseline Characteristics

Rhythm Evaluation for AntiCoagulaTion With COntinuous Monitoring

Baseline characteristics by cohort

Measure	Non-Coumadin Oral Anticoagulant n=59 Participants Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device. Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants
Age, Categorical >=65 years	38 Participants n=5 Participants
Age, Continuous	66.8 year STANDARD_DEVIATION 7.7 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	55 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Canada	12 participants n=5 Participants
Region of Enrollment United States	47 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 12 months

Assess subject anticoagulant utilization and number of days on anticoagulation

Outcome measures

Measure	Non-Coumadin Oral Anticoagulant n=59 Participants Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device. Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.
Number of Days on Anticoagulation	24.9 days Standard Deviation 51.9

SECONDARY outcome

Timeframe: up to 12 months

To assess the bleeding incidence with implantable monitor-guided intermittent anticoagulation.

Outcome measures

Measure	Non-Coumadin Oral Anticoagulant n=59 Participants Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device. Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.
Bleeding Incidence	3 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

To assess the stroke rate with implantable monitor-guided intermittent anticoagulation.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

To assess the overall survival rate with implantable monitor-guided intermittent anticoagulation.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

To assess the major bleeding-free survival rate with implantable monitor-guided intermittent anticoagulation.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

To assess the stroke-free survival rate with implantable monitor-guided intermittent anticoagulation.

Outcome measures

Outcome data not reported

Adverse Events

Non-Coumadin Oral Anticoagulant

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Non-Coumadin Oral Anticoagulant n=59 participants at risk Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device. Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.
Nervous system disorders TIA	5.1% 3/59 • Number of events 3

Other adverse events

Measure	Non-Coumadin Oral Anticoagulant n=59 participants at risk Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device. Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.
Vascular disorders Minor bleeding	5.1% 3/59
Vascular disorders Major Bleeding	3.4% 2/59 • Number of events 2
Cardiac disorders Development of Permanent Atrial Fibrillation	1.7% 1/59 • Number of events 1
Blood and lymphatic system disorders Dual antiplatelet therapy	1.7% 1/59 • Number of events 1

Additional Information

Adin-Cristian Andrei, Ph.D.

Northwestern University

Phone: 312-694-0509

Email: Adin-Cristian.Andrei@nm.org

Results disclosure agreements

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