Trial Outcomes & Findings for Safety Study on Stopping Anticoagulation Medication in Patients With a History of Atrial Fibrillation (NCT NCT01650298)
NCT ID: NCT01650298
Last Updated: 2020-08-13
Results Overview
To assess the reduction in time on anticoagulation, the cumulative total number of days on anticoagulation for each group throughout the follow-up period was determined. This study was designed as a pilot/feasibility study and therefore was not powered to detect thromboembolic events. Per study protocol, all patients completed a 30 day run-in period following enrollment during which anticoagulation could not be stopped regardless of AT/AF burden.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
64 participants
Primary outcome timeframe
one year
Results posted on
2020-08-13
Participant Flow
Participant milestones
| Measure |
Anticoagulation Taken as Prescribed by Doctor
Anticoagulation presciption will be taken per physician's discretion
|
Anticoagulation to be Stopped/Started Per Device Information
Other: The physician will manage the patient's anticoagulation medication by weekly remote monitoring device transmissions
Drug (Direct thrombin or Factor Xa inhibitor): Patient will stop or restart drug per cardiac device information (AT/AF diagnostics for prespecified AT/AF episode duration per day and total burden).
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
48
|
|
Overall Study
COMPLETED
|
11
|
42
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety Study on Stopping Anticoagulation Medication in Patients With a History of Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
Control
n=16 Participants
Remote transmissions were scheduled per each institution's device monitoring protocol. Anticoagulation was initiated/discontinued based on standard of care/guidelines as prescribed by doctor.
|
Tailored Anticoagulation
n=48 Participants
Tailored Anticoagulation (TAC): Anticoagulation to be stopped/started per device information. Patients sent in biweekly remote transmissions, automatic alert-triggered transmissions for AT/AF burden above a set threshold, and unscheduled patient-activated transmissions as needed.
Drug (Direct thrombin or Factor Xa inhibitor): Patient will stop or restart drug per cardiac device information (AT/AF diagnostics for prespecified AT/AF episode duration per day and total burden).
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Age, Continuous
|
75.0 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
71.3 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
72.2 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
48 participants
n=7 Participants
|
64 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: one yearPopulation: After a 30-day run-in period during which anticoagulation use could not be stopped per study protocol, a total of 14,826 cumulative days of monitoring were completed.
To assess the reduction in time on anticoagulation, the cumulative total number of days on anticoagulation for each group throughout the follow-up period was determined. This study was designed as a pilot/feasibility study and therefore was not powered to detect thromboembolic events. Per study protocol, all patients completed a 30 day run-in period following enrollment during which anticoagulation could not be stopped regardless of AT/AF burden.
Outcome measures
| Measure |
Control
n=16 Participants
Anticoagulation medication was per doctor's discretion / standard of care (continuous coagulation)
|
Tailored Anticoagulation
n=48 Participants
Anticoagulation medication was based on patient's AT/AF information from device
|
|---|---|---|
|
Total Cumulative Days on Anticoagulation
|
5840 days on anticoagulation
|
3763 days on anticoagulation
|
Adverse Events
Anticoagulation Taken as Prescribed by Doctor
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Anticoagulation to be Stopped/Started Per Device Information
Serious events: 8 serious events
Other events: 9 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Anticoagulation Taken as Prescribed by Doctor
n=16 participants at risk
Anticoagulation medication was per doctor's discretion
|
Anticoagulation to be Stopped/Started Per Device Information
n=48 participants at risk
Anticoagulation medication was based on patient's AT/AF information from device
|
|---|---|---|
|
Gastrointestinal disorders
Hemorrahagic event
|
6.2%
1/16 • Number of events 1
|
0.00%
0/48
|
|
Cardiac disorders
DECOMPENSATED HF
|
6.2%
1/16 • Number of events 1
|
0.00%
0/48
|
|
Cardiac disorders
ATRIAL ARRHYTHMIA
|
6.2%
1/16 • Number of events 2
|
12.5%
6/48 • Number of events 7
|
|
Nervous system disorders
HEMORRHAGIC EVENT
|
0.00%
0/16
|
2.1%
1/48 • Number of events 1
|
|
Infections and infestations
INFECTION
|
0.00%
0/16
|
2.1%
1/48 • Number of events 1
|
Other adverse events
| Measure |
Anticoagulation Taken as Prescribed by Doctor
n=16 participants at risk
Anticoagulation medication was per doctor's discretion
|
Anticoagulation to be Stopped/Started Per Device Information
n=48 participants at risk
Anticoagulation medication was based on patient's AT/AF information from device
|
|---|---|---|
|
Cardiac disorders
ATRIAL ARRHYTHMIA
|
6.2%
1/16 • Number of events 1
|
4.2%
2/48 • Number of events 3
|
|
General disorders
HEMORRHAGIC EVENT
|
6.2%
1/16 • Number of events 1
|
0.00%
0/48
|
|
Vascular disorders
HEMORRHAGIC EVENT
|
12.5%
2/16 • Number of events 2
|
0.00%
0/48
|
|
Cardiac disorders
LV Thrombus
|
6.2%
1/16 • Number of events 1
|
0.00%
0/48
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
6.2%
1/16 • Number of events 1
|
0.00%
0/48
|
|
Gastrointestinal disorders
HEMORRHAGIC EVENT
|
0.00%
0/16
|
4.2%
2/48 • Number of events 2
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/16
|
2.1%
1/48 • Number of events 1
|
|
Gastrointestinal disorders
DIVERTICULITIS
|
0.00%
0/16
|
2.1%
1/48 • Number of events 1
|
|
General disorders
SYNCOPE
|
0.00%
0/16
|
2.1%
1/48 • Number of events 1
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/16
|
2.1%
1/48 • Number of events 1
|
|
Product Issues
OVERSENSING
|
0.00%
0/16
|
2.1%
1/48 • Number of events 1
|
|
Injury, poisoning and procedural complications
RADIAL HEAD FRACTURE
|
0.00%
0/16
|
2.1%
1/48 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place