Rhythm Control of AF in Patients With Acute Stroke
Primary Purpose
Atrial Fibrillation
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rhythm control
Rate control
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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%
- 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
Sites / Locations
- Severance Cardiovascular Hospital, Yonsei University Health SystemRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Rhythm control group
Rate control group
Arm Description
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
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.
Outcomes
Primary Outcome Measures
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
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02285387
Brief Title
Rhythm Control of AF in Patients With Acute Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
August 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rhythm control group
Arm Type
Experimental
Arm Description
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
Arm Title
Rate control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Rhythm control
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Rate control
Intervention Description
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.
Primary Outcome Measure Information:
Title
acute stroke with AF
Description
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
Time Frame
1 year
Title
recurrence of silence stroke
Description
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
Time Frame
1 year
Title
recurrence of AF after rhythm control
Description
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
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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%
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui-Na Pak, MD
Phone
82-2-2228-8459
Facility Information:
Facility Name
Severance Cardiovascular Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui-Nam Pak, M.D., Ph.D.
Phone
82-2-2228-8459
Email
hnpak@yuhs.ac
12. IPD Sharing Statement
Citations:
PubMed Identifier
35043663
Citation
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.
Results Reference
derived
Learn more about this trial
Rhythm Control of AF in Patients With Acute Stroke
We'll reach out to this number within 24 hrs