Atrial FibrillationTACTIC AFNCT01650298
Safety Study on Stopping Anticoagulation Medication in Patients With a History of Atrial Fibrillation
A study testing Drug (Direct thrombin or Factor Xa inhibitor) in people with Atrial Fibrillation, run by Abbott Medical Devices at 10 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Drug (Direct thrombin or Factor Xa inhibitor)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 10 sitesUnited States
- Study dates
- Jan 2013to Aug 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Samaritan Heart and Vascular Institute
Corvallis, Oregon, 97330
Hackensack University Medical Center
Hackensack, New Jersey, 76011
Sparrow Research Institute
Lansing, Michigan, 48912
Jeffrey Goodman, MD
Los Angeles, California, 90048
Jefferson Heart Institute
Philadelphia, Pennsylvania, 19107
Allegheny Singer Research Institute
Pittsburgh, Pennsylvania, 15212
STAR Clinical Trials, LLC / Cardiology Clinic of San Antonio
San Antonio, Texas, 78229
About this study
Official title: Pilot Study: Tailored Anticoagulation for Noncontinuous AF
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).
- Conditions
- Atrial Fibrillation
- Being tested
- Drug (Direct thrombin or Factor Xa inhibitor)
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug (Direct thrombin or Factor Xa inhibitor)Other
Patient will stop or restart drug per cardiac device information (AT/AF diagnostics for prespecified AT/AF episode duration per day and total burden).
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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) | Experimental | 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 Receives: Other: Drug (Direct thrombin or Factor Xa inhibitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Cumulative Days on Anticoagulation
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startJan 2013
- Primary completionDec 2016
- Study completionAug 2017
Why it stopped: Due to slow enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Zimetbaum, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01650298
- Sponsor's protocol ID
- 60039204/C
- Acronym
- TACTIC AF
- Status last verified
- Aug 2020
- First submitted
- 23 Jul 2012
- Last updated
- 13 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Tailored Anticoagulation for Noncontinuous AF
- ClinicalTrials.gov ID
- NCT01650298
- Acronym / sponsor ID
- TACTIC AF / 60039204/C
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to slow enrollment.
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jan 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 26 Jul 2012 (estimated)
- Results
- Posted 13 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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) | Experimental | Other: Drug (Direct thrombin or Factor Xa inhibitor)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | Tailored Anticoagulation (TAC) |
Primary outcome
Total Cumulative Days on Anticoagulation
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Zimetbaum, MD principal investigator
Beth Israel Deaconess Medical Center
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug (Direct thrombin or Factor Xa inhibitor) in people with Atrial Fibrillation, run by Abbott Medical Devices at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Cumulative Days on Anticoagulation (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020.