TACTIC AF: Safety Study on Stopping Anticoagulation Medication in Patients With a History of Atrial Fibrillation

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01650298
• Collaborator: (none)
• Enrollment: 64
• Locations: 10
• Arms: 2
• Actual Duration (Months): 55
• Patients Per Site: 6.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether it is safe to stop anticoagulation medication in patients with a history of atrial fibrillation (AF) based on information from a pacemaker or implantable cardioverter defibrillator (ICD).

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Other: Drug (Direct thrombin or Factor Xa inhibitor)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Pilot Study: Tailored Anticoagulation for Noncontinuous AF
• Actual Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control 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
Experimental: Tailored Anticoagulation (TAC) Anticoagulation was initiated or discontinued based on atrial tachycardia / atrial fibrillation (AT/AF) burden as assessed through frequent remote transmissions via Merlin.net. 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	Other: 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).

Outcome Measures

Primary Outcome Measures

1. Total Cumulative Days on Anticoagulation [one year]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient has a St Jude Medial device that is compatible with Merlin.net (remote monitoring)

• Patient has history of atrial fibrillation (non-continuous)

• Patient must be taking a a blood thinner medication other than warfarin or aspirin for atrial fibrillation

• Patient is willing to complete a questionnaire

Exclusion Criteria:

• Patient is in atrial fibrillation all of the time

• Patient has a history of stroke or blood clot

• Patient is on warfarin or coumadin

• Patient cannot be taken off of his blood thinner medication due to another medical condition

• Patient is not capable of sending a remote device transmission to doctor once a week

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jeffrey Goodman, MD	Los Angeles	California	United States	90048
2	Northwestern Memorial Hospital	Chicago	Illinois	United States	60611
3	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
4	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
5	Sparrow Research Institute	Lansing	Michigan	United States	48912
6	Hackensack University Medical Center	Hackensack	New Jersey	United States	76011
7	Samaritan Heart and Vascular Institute	Corvallis	Oregon	United States	97330
8	Jefferson Heart Institute	Philadelphia	Pennsylvania	United States	19107
9	Allegheny Singer Research Institute	Pittsburgh	Pennsylvania	United States	15212
10	STAR Clinical Trials, LLC / Cardiology Clinic of San Antonio	San Antonio	Texas	United States	78229

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: Peter Zimetbaum, MD, Beth Israel Deaconess Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT01650298
• Other Study ID Numbers: 60039204/C
• First Posted: Jul 26, 2012
• Last Update Posted: Aug 13, 2020
• Last Verified: Aug 1, 2020

• Additional relevant MeSH terms: Atrial Fibrillation; Factor Xa Inhibitors; Thrombin

Study Results

Participant Flow

Arm/Group Title	Anticoagulation Taken as Prescribed by Doctor	Anticoagulation to be Stopped/Started Per Device Information
Arm/Group Description	Anticoagulation presciption will be taken per physician's discretion	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).
Period Title: Overall Study
STARTED	16	48
COMPLETED	11	42
NOT COMPLETED	5	6

Baseline Characteristics

Arm/Group Title	Control	Tailored Anticoagulation	Total
Arm/Group Description	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 (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 of all reporting groups
Overall Participants	16	48	64
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	3 18.8%	12 25%	15 23.4%
>=65 years	13 81.3%	36 75%	49 76.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	75.0 (11.1)	71.3 (10.2)	72.2 (10.4)
Sex: Female, Male (Count of Participants)
Female	6 37.5%	17 35.4%	23 35.9%
Male	10 62.5%	31 64.6%	41 64.1%
Region of Enrollment (participants) [Number]
United States	16 100%	48 100%	64 100%

Outcome Measures

1. Primary Outcome

Title	Total Cumulative Days on Anticoagulation
Description	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.
Time Frame	one year

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Control	Tailored Anticoagulation
Arm/Group Description	Anticoagulation medication was per doctor's discretion / standard of care (continuous coagulation)	Anticoagulation medication was based on patient's AT/AF information from device
Measure Participants	16	48
Number [days on anticoagulation]	5840	3763

Adverse Events

Arm/Group Title	Anticoagulation Taken as Prescribed by Doctor		Anticoagulation to be Stopped/Started Per Device Information
Arm/Group Description	Anticoagulation medication was per doctor's discretion		Anticoagulation medication was based on patient's AT/AF information from device
All Cause Mortality
	Anticoagulation Taken as Prescribed by Doctor		Anticoagulation to be Stopped/Started Per Device Information
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		2/48 (4.2%)
Serious Adverse Events
	Anticoagulation Taken as Prescribed by Doctor		Anticoagulation to be Stopped/Started Per Device Information
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/16 (18.8%)		8/48 (16.7%)
Cardiac disorders
DECOMPENSATED HF	1/16 (6.3%)	1	0/48 (0%)	0
ATRIAL ARRHYTHMIA	1/16 (6.3%)	2	6/48 (12.5%)	7
Gastrointestinal disorders
Hemorrahagic event	1/16 (6.3%)	1	0/48 (0%)	0
Infections and infestations
INFECTION	0/16 (0%)	0	1/48 (2.1%)	1
Nervous system disorders
HEMORRHAGIC EVENT	0/16 (0%)	0	1/48 (2.1%)	1
Other (Not Including Serious) Adverse Events
	Anticoagulation Taken as Prescribed by Doctor		Anticoagulation to be Stopped/Started Per Device Information
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/16 (31.3%)		9/48 (18.8%)
Cardiac disorders
ATRIAL ARRHYTHMIA	1/16 (6.3%)	1	2/48 (4.2%)	3
LV Thrombus	1/16 (6.3%)	1	0/48 (0%)	0
CORONARY ARTERY DISEASE	0/16 (0%)	0	1/48 (2.1%)	1
Gastrointestinal disorders
HEMORRHAGIC EVENT	0/16 (0%)	0	2/48 (4.2%)	2
DIVERTICULITIS	0/16 (0%)	0	1/48 (2.1%)	1
General disorders
HEMORRHAGIC EVENT	1/16 (6.3%)	1	0/48 (0%)	0
SYNCOPE	0/16 (0%)	0	1/48 (2.1%)	1
Infections and infestations
PNEUMONIA	0/16 (0%)	0	1/48 (2.1%)	1
Injury, poisoning and procedural complications
RIB FRACTURE	1/16 (6.3%)	1	0/48 (0%)	0
RADIAL HEAD FRACTURE	0/16 (0%)	0	1/48 (2.1%)	1
Product Issues
OVERSENSING	0/16 (0%)	0	1/48 (2.1%)	1
Vascular disorders
HEMORRHAGIC EVENT	2/16 (12.5%)	2	0/48 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

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.