Persistent Atrial FibrillationNCT02633774
Comparison of Brain Perfusion in Rhythm Control and Rate Control of Persistent Atrial Fibrillation
A study testing Propafenone and Apixaban in people with Persistent Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
Trial summary
Atrial fibrillation (AF) is associated with impaired cognitive function (CogF) and/or dementia, but it is unclear whether rhythm control of AF improves CogF or brain perfusion. The hypothesis is rhythm control of AF improves CogF by increasing brain perfusion with hemodynamic amelioration compared to AF state. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Propafenone and Apixaban
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2015to Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with persistent Atrial fibrillation (20~80 years old)
- LA diameter < 55mm
- patients possible to anticoagulation and anti arrhythmic drug
Who cannot join
- Structural cardiac disease
- Contraindication to brain perfusion CT
- Catheter ablation history for AF, Cardiac surgery
- active internal bleeding
- Impossible to anticoagulation or antiarrhythmic drug
- valvular AF ((MA> GII, Mechanical valve, Mitral valve replacement)
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- LVEF < 30%
- With severe medical disease
- Expected survival < 1 year
- Severe alcoholics, drug addiction
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Cardiovascular Hospital, Yonsei University Health System
Seoul, 120-752
Hui-Nam Pak, M.D., Ph.D., 82-2-2228-8459, hnpak@yuhs.ac
About this study
Official title: Comparison of Brain Perfusion in Rhythm Control and Rate Control of Persistent Atrial Fibrillation: Prospective Randomized Trial
Atrial fibrillation (AF) is associated with impaired cognitive function (CogF) and/or dementia, but it is unclear whether rhythm control of AF improves CogF or brain perfusion. The hypothesis is rhythm control of AF improves CogF by increasing brain perfusion with hemodynamic amelioration compared to AF state. We will randomize the patients with persistent AF to rhythm control group and rate control group, and check baseline and 3rd month cognitive function (K-MOCA score) and brain perfusion CT. K-MOCA score and brain perfusion CT findings will be compared between rhythm control group and rate control group of persistent AF.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Propafenone, Apixaban
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropafenoneDrug
AAD(antiarrhythmic drug)
ApixabanDrug
anti-coagulation
| Study group | Role | What they receive |
|---|---|---|
| Rhythm control group | Active comparator | 1. Start AAD right after evaluating for LA size, EF, LA thrombus, and presence of CAD during anticoagulation 2. check the echo, brain perfusion CT and K-MOCA on baseline 3. confirm a thrombus through the TEE 4. Cardioversion after 1 month 5. Rhythm FU schedule (2012 ACC/AHA/ESC guidelines) 6. If AF recur, RFCA 7. check the brain perfusion CT, K-MOCA after 3M and 12M Receives: Drug: Propafenone |
| Rate control group | Active comparator | 1. No AAD, just anticoagulation 2. HR control between 60~110bpm (with beta blocker, calcium channel blocker, digoxin) 3. check the echo, brain perfusion CT and K-MOCA on baseline 4. check the brain perfusion CT and K-MOCA after 3M and 12M 5. Without the treatment about antiarrythmia and rhythm control, diffication of rate control, the subject will be drop out for study. Receives: Drug: Apixaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
K-MOCA(Korean version of Montreal Cognitive Assessment)
Measured: 12 months after the enrollment
Brain perfusion CT
Measured: 12 months after the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02633774
- Sponsor's protocol ID
- 4-2015-0914
- Status last verified
- Jan 2019
- First submitted
- 7 Dec 2015
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Brain Perfusion in Rhythm Control and Rate Control of Persistent Atrial Fibrillation: Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT02633774
- Acronym / sponsor ID
- 4-2015-0914
- Conditions
- Persistent Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atrial fibrillation (AF) is associated with impaired cognitive function (CogF) and/or dementia, but it is unclear whether rhythm control of AF improves CogF or brain perfusion. The hypothesis is rhythm control of AF improves CogF by increasing brain perfusion with hemodynamic amelioration compared to AF state. We will randomize the patients with persistent AF to rhythm control group and rate control group, and check baseline and 3rd month cognitive function (K-MOCA score) and brain perfusion CT. K-MOCA score and brain perfusion CT findings will be compared between rhythm control group and rate control group of persistent AF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rhythm control group | Active comparator | Drug: Propafenone1. Start AAD right after evaluating for LA size, EF, LA thrombus, and presence of CAD during anticoagulation 2. check the echo, brain perfusion CT and K-MOCA on baseline 3. confirm a thrombus through the TEE 4. Cardioversion after 1 month 5. Rhythm FU schedule (2012 ACC/AHA/ESC guidelines) 6. If AF recur, RFCA 7. check the brain perfusion CT, K-MOCA after 3M and 12M |
| Rate control group | Active comparator | Drug: Apixaban1. No AAD, just anticoagulation 2. HR control between 60~110bpm (with beta blocker, calcium channel blocker, digoxin) 3. check the echo, brain perfusion CT and K-MOCA on baseline 4. check the brain perfusion CT and K-MOCA after 3M and 12M 5. Without the treatment about antiarrythmia and rhythm control, diffication of rate control, the subject will be drop out for study. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with persistent Atrial fibrillation (20~80 years old)
- LA diameter < 55mm
- patients possible to anticoagulation and anti arrhythmic drug
Key exclusion criteria (10 listed)
- Structural cardiac disease
- Contraindication to brain perfusion CT
- Catheter ablation history for AF, Cardiac surgery
- active internal bleeding
- Impossible to anticoagulation or antiarrhythmic drug
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 |
|---|---|---|
| PropafenoneAAD(antiarrhythmic drug) | Drug | Rhythm control group |
| Apixabananti-coagulation | Drug | Rate control group |
Primary outcome
K-MOCA(Korean version of Montreal Cognitive Assessment)
Time frame: 12 months after the enrollment
Brain perfusion CT
Time frame: 12 months after the enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2019.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propafenone and Apixaban in people with Persistent Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 28 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui-Nam Park, MD, Ph.D (82-2-2228-8459, hnpak@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
K-MOCA(Korean version of Montreal Cognitive Assessment) (time frame: 12 months after the enrollment). The study lists 2 primary outcomes in all. 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 28 Jan 2019.