Rhythm Control of AF in Patients With Acute Stroke
1 other identifier
interventional
300
1 country
1
Brief 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.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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable atrial-fibrillation
Started Nov 2014
Longer than P75 for not_applicable atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedFirst Posted
Study publicly available on registry
November 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedMarch 26, 2019
March 1, 2019
4.8 years
October 31, 2014
March 25, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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
1 year
Study Arms (2)
Rhythm control group
EXPERIMENTAL1. 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 COMPARATOR1. 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.
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- \. Contraindication to MRI 15. Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Severance Cardiovascular Hospital, Yonsei University Health System
Seoul, 120-752, South Korea
Related Publications (1)
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.
PMID: 35043663DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2014
First Posted
November 7, 2014
Study Start
November 1, 2014
Primary Completion
August 1, 2019
Study Completion
August 1, 2019
Last Updated
March 26, 2019
Record last verified: 2019-03