Atrial FibrillationNCT02285387
Rhythm Control of AF in Patients With Acute Stroke
A study of Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
Trial summary
Prospective randomized (rhythm control or rate control) Objective of study 1. To analyze long term outcome of patients with acute stroke with atrial fibrillation according to the rhythm control 2. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atrial Fibrillation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2014to Aug 2019
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Atrial fibrillation (20~80 years old)
- patients with Acute stroke within 7 days
- LA diameter < 55mm
- patients possible to anticoagulation and anti arrhythmic drug
- NIHSS score ≤12
Who cannot join
- Hemorrhagic transformation
- Large cerebral lesion or cerebellar lesion (more than 1/3 of MCA area and 1/2 of ACA area, 1/2 of PCA area, 1/2 of cerebellar area)
- active internal bleeding
- Impossible to anticoagulation or anti arrhythmic drug
- Valvular AF (MA> GII, Mechanical valve, Mitral valve replacement)
- LV ejection fraction < 30%
Show all 13Show fewer
- Structural cardiac disease
- Catheter ablation history for AF, Cardiac surgery
- Already prescribed anti arrhythmic drugs
- With severe medical disease
- Expected survival < 1year
- Severe alcoholics, drug addiction
- 14. Contraindication to MRI 15. Pregnancy
Trial locations and contacts
1 site in 1 country.
Hui-Na Pak, MD contact
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
Prospective randomized (rhythm control or rate control) Objective of study
- To analyze long term outcome of patients with acute stroke with atrial fibrillation according to the rhythm control
- To analyze recurrence rate of atrial fibrillation or recurrence stroke in patients with acute stroke according to the rhythm control (by antiarrhythmic drug, cardioversion, catheter ablation)
- Conditions
- Atrial Fibrillation
- Being tested
- Rhythm control, Rate control
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythm controlProcedure or surgery
- Start AAD right after evaluating for LA size, EF, LA thrombus, and presence of CAD during anticoagulation
- Cardioversion after 1 month
- Rhythm FU schedule (2012 ACC/AHA/ESC guidelines)
- If AF recur, RFCA
Rate controlProcedure or surgery
- No AAD, just anticoagulation
- HR control between 60~110bpm (with beta blocker, calcium channel blocker, digoxin)
- Without the treatment about antiarrhythmia and rhythm control, deification of rate control, the subject will be drop out for study.
| Study group | Role | What they receive |
|---|---|---|
| Rhythm control group | Experimental | 1. Start AAD right after evaluating for LA size, EF, LA thrombus, and presence of CAD during anticoagulation
2. Cardioversion after 1 month
3. Rhythm FU schedule (2012 ACC/AHA/ESC guidelines)
4. If AF recur, RFCA Receives: Procedure: Rhythm control |
| Rate control group | Active comparator | 1. No AAD, just anticoagulation
2. HR control between 60~110bpm (with beta blocker, calcium channel blocker, digoxin)
3. Without the treatment about antiarrhythmia and rhythm control, deification of rate control, the subject will be drop out for study. Receives: Procedure: Rate control |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute stroke with AF
Long term outcome of rhythm control in patients with acute stroke with AF related to all cause morality, hospital admission, recurrence rate of stroke, major adverse cardiac events
Measured: 1 year
recurrence of silence stroke
Adverse events after anticoagulation or anti arrhythmic drug, recurrence rate after RFCA on AF in patients with stroke, adverse events after RFCA, recurrence rate of silence stroke or clinical stroke
Measured: 1 year
recurrence of AF after rhythm control
Adverse events after anticoagulation or anti arrhythmic drug, recurrence rate after RFCA on AF in patients with stroke, adverse events after RFCA, recurrence rate of silence stroke or clinical stroke
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionAug 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 300 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
- NCT02285387
- Sponsor's protocol ID
- 4-2014-0728
- Status last verified
- Mar 2019
- First submitted
- 31 Oct 2014
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Park J, Shim J, Lee JM, Park JK, Heo J, Chang Y, Song TJ, Kim DH, Lee HA, Yu HT, Kim TH, Uhm JS, Kim YD, Nam HS, Joung B, Lee MH, Heo JH, Pak HN; RAFAS Investigators*. Risks and Benefits of Early Rhythm Control in Patients With Acute Strokes and Atrial Fibrillation: A Multicenter, Prospective, Randomized Study (the RAFAS Trial). J Am Heart Assoc. 2022 Feb;11(3):e023391. doi: 10.1161/JAHA.121.023391. Epub 2022 Jan 19.
PubMed 35043663
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rhythm Control of AF in Patients With Acute Stroke
- ClinicalTrials.gov ID
- NCT02285387
- Acronym / sponsor ID
- 4-2014-0728
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 7 Nov 2014 (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.
Prospective randomized (rhythm control or rate control) Objective of study
- To analyze long term outcome of patients with acute stroke with atrial fibrillation according to the rhythm control
- To analyze recurrence rate of atrial fibrillation or recurrence stroke in patients with acute stroke according to the rhythm control (by antiarrhythmic drug, cardioversion, catheter ablation)
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 | Experimental | Procedure: Rhythm control1. Start AAD right after evaluating for LA size, EF, LA thrombus, and presence of CAD during anticoagulation 2. Cardioversion after 1 month 3. Rhythm FU schedule (2012 ACC/AHA/ESC guidelines) 4. If AF recur, RFCA |
| Rate control group | Active comparator | Procedure: Rate control1. No AAD, just anticoagulation 2. HR control between 60~110bpm (with beta blocker, calcium channel blocker, digoxin) 3. Without the treatment about antiarrhythmia and rhythm control, deification of rate control, the subject will be drop out for study. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with Atrial fibrillation (20~80 years old)
- patients with Acute stroke within 7 days
- LA diameter < 55mm
- patients possible to anticoagulation and anti arrhythmic drug
- NIHSS score ≤12
Key exclusion criteria (13 listed)
- Hemorrhagic transformation
- Large cerebral lesion or cerebellar lesion (more than 1/3 of MCA area and 1/2 of ACA area, 1/2 of PCA area, 1/2 of cerebellar area)
- active internal bleeding
- Impossible to anticoagulation or anti arrhythmic drug
- Valvular AF (MA> GII, Mechanical valve, Mitral valve replacement)
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 |
|---|---|---|
| Rhythm control1. Start AAD right after evaluating for LA size, EF, LA thrombus, and presence of CAD during anticoagulation 2. Cardioversion after 1 month 3. Rhythm FU schedule (2012 ACC/AHA/ESC guidelines) 4. If AF recur, RFCA | Procedure or surgery | Rhythm control group |
| Rate control1. No AAD, just anticoagulation 2. HR control between 60~110bpm (with beta blocker, calcium channel blocker, digoxin) 3. Without the treatment about antiarrhythmia and rhythm control, deification of rate control, the subject will be drop out for study. | Procedure or surgery | Rate control group |
Primary outcome
acute stroke with AF
Time frame: 1 year
Long term outcome of rhythm control in patients with acute stroke with AF related to all cause morality, hospital admission, recurrence rate of stroke, major adverse cardiac events
recurrence of silence stroke
Time frame: 1 year
Adverse events after anticoagulation or anti arrhythmic drug, recurrence rate after RFCA on AF in patients with stroke, adverse events after RFCA, recurrence rate of silence stroke or clinical stroke
recurrence of AF after rhythm control
Time frame: 1 year
Adverse events after anticoagulation or anti arrhythmic drug, recurrence rate after RFCA on AF in patients with stroke, adverse events after RFCA, recurrence rate of silence stroke or clinical stroke
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Derived from this study: PubMed 35043663Park J, Shim J, Lee JM, Park JK, Heo J, Chang Y, Song TJ, Kim DH, Lee HA, Yu HT, Kim TH, Uhm JS, Kim YD, Nam HS, Joung B, Lee MH, Heo JH, Pak HN; RAFAS Investigators*. Risks and Benefits of Early Rhythm Control in Patients With Acute Strokes and Atrial Fibrillation: A Multicenter, Prospective, Randomized Study (the RAFAS Trial). J Am Heart Assoc. 2022 Feb;11(3):e023391. doi: 10.1161/JAHA.121.023391. Epub 2022 Jan 19.
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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.
Hui-Na Pak, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of 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 5 inclusion and 13 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 26 Mar 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-Na Pak, MD (82-2-2228-8459), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute stroke with AF (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02285387, which also lists 1 linked publication.
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 26 Mar 2019.