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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
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with Atrial fibrillation (20~80 years old)
  2. patients with Acute stroke within 7 days
  3. LA diameter < 55mm
  4. patients possible to anticoagulation and anti arrhythmic drug
  5. NIHSS score ≤12

Exclusion Criteria:

  1. Hemorrhagic transformation
  2. 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)
  3. active internal bleeding
  4. Impossible to anticoagulation or anti arrhythmic drug
  5. Valvular AF (MA> GII, Mechanical valve, Mitral valve replacement)
  6. LV ejection fraction < 30%
  7. Structural cardiac disease
  8. Catheter ablation history for AF, Cardiac surgery
  9. Already prescribed anti arrhythmic drugs
  10. With severe medical disease
  11. Expected survival < 1year
  12. 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

First Posted
October 31, 2014
Last Updated
March 25, 2019
Sponsor
Yonsei University
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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
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Rhythm Control of AF in Patients With Acute Stroke

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