임상연구정보서비스

Search: Search

Rhythm control of AF in patients with acute stroke

Status Approved

First Submitted Date

2019/02/15
Registered Date

2019/03/25
Last Updated Date

2019/09/03

Move list page

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0003667
Unique Protocol ID	4-2014-0728
Public/Brief Title	Rhythm control of AF in patients with acute stroke
Scientific Title	Rhythm control of AF in patients with acute stroke
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	Yes
Name of Registry / Registration Number	ClinicalTrials.gov-NCT02285387
Healthcare Benefit Approval Status	Submitted approval

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	4-2014-0728
Approval Date	2014-10-14
Institutional Review Board Name	Yonsei University Health system, Severance Hospital, Institutional Review Board
Institutional Review Board Address	50-1, Yonsei-ro, Seodaemun-gu, Seoul
Institutional Review Board Telephone	02-2228-0435
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	HUI NAM PAK
Title	Professor
Telephone	+82-2-2228-8459
Affiliation	Yonsei University Health System, Severance Hospital
Address	50-1, Yonsei-ro, Seodaemun-gu, Seoul
Contact Person for Public Queries
Name	SO HEE JOO
Title	Study coordinator
Telephone	+82-2-2228-8528
Affiliation	Yonsei University Health System, Severance Hospital
Address	50-1, Yonsei-ro, Seodaemun-gu, Seoul
Contact Person for Updating Information
Name	HEEJOO HA
Title	Study coordinator
Telephone	+82-2-2228-0557
Affiliation	Yonsei University Health System, Severance Hospital
Address	50-1, Yonsei-ro, Seodaemun-gu, Seoul

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Multi-center Number of center : 3
Overall Recruitment Status	Recruiting
Date of First Enrollment	2014-11-10 Actual
Target Number of Participant	300
Primary Completion Date	2021-08-31 , Anticipated
Study Completion Date	2021-08-31 , Anticipated
Name of Study	Yonsei University Health System, Severance Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2014-11-10 ,
Recruitment Status by Participating Study Site 2
Name of Study	Ewha Womans University Medical Center
Recruitment Status	Recruiting
Date of First Enrollment	2019-08-24 ,
Recruitment Status by Participating Study Site 3
Name of Study	Kyung Hee University Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2019-10-01 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Yonsei University Health System, Severance Hospital
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Yonsei University Health System, Severance Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	1. For atrial fibrillation accompanied by acute cerebral infarction, we want to evaluate the adequacy and long-term outcome by comparing rhythm control and rate control 2. To evaluate the frequency of recurrence of silent atrial fibrillation, which can occur during the control of the rhythm in brain infarction patients and to analyze the difference in frequency of asymptomatic cerebral infarction in rhythmic and rate control groups.

Study Summary Information

Lay Summary

1. For atrial fibrillation accompanied by acute cerebral infarction, we want to evaluate the adequacy and long-term outcome by comparing rhythm control and rate control 
2. To evaluate the frequency of recurrence of silent atrial fibrillation, which can occur during the control of the rhythm in brain infarction patients and to analyze the difference in frequency of asymptomatic cerebral infarction in rhythmic and rate control groups.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Open
Allocation	RCT
Intervention Type	Drug, /Procedure/Surgery
Intervention Description	prospective randomized - Rhythm Control group : Rate Control Group = 2:1 - Rhythm Control group : AAD : Atrial Antiarrhythmic Drugs (amiodarone), cardioversion, radiofrequency ablation - Rate Control Group : anticoagulation(beta blocker, calcium channel blocker, digoxin) *According to the patient's characteristics, capacity, number and duration of the drug is subject to the doctor's judgment
Number of Arms	2
Arm 1	Arm Label Rhythm Control group
	Target Number of Participant 200
	Arm Type Experimental
	Arm Description 1. No AAD(Atrial Antiarrhythmic Drugs), just anticoagulation 2. heart rate control between 60~110bpm (with beta blocker, calcium channel blocker, digoxin) - According to the patient's characteristics, the selection of the pulse control medicine is subject to the doctor's judgment 3. Without treatment for the antiarrhythmic drug and the rhythm control, the patient will drop out in this study in case rate control is difficult and the patient has difficulty controlling symptoms
Arm 2	Arm Label Rate Control Group
	Target Number of Participant 100
	Arm Type Active comparator
	Arm Description 1. No AAD(Atrial Antiarrhythmic Drugs), just anticoagulation 2. heart rate control between 60~110bpm (with beta blocker, calcium channel blocker, digoxin) - According to the patient's characteristics, the selection of the pulse control medicine is subject to the doctor's judgment 3. Without treatment for the antiarrhythmic drug and the rhythm control, the patient will drop out in this study in case rate control is difficult and the patient has difficulty controlling symptoms

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (I00-I99)Diseases of the circulatory system (I63.9)Cerebral infarction, unspecified Atrial Fibrillation , Stroke
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~80Year
	Description 1. Atrial fibrillation patients aged 20 to 80 2. Acute cerebral infarction or transient ischemic attack, which is estimated to be cardiac embolism within seven days of the stroke. 3. Left atrium size of an atrial fibrillation patient < 55mm 4. Patients capable of anticoagulation and antiarrhythmic drugs 5. NIHSS(National Institutes of Health Stroke Scale) score ≤ 12 and the neurological condition is capable of outpatient follow up.
Exclusion Criteria	1. Patient with significant hemorrhagic transformation 2. cerebral hemispheres infarction or cerebellum infarction patient(The size of cerebral infarction is more than 1/3 of the MCA(middle cerebral artery), 1/2 of the ACA(anterior cerebral artery), 1/2 of the PCA(posterior cerebral artery), and 1/2 of the cerebellum) 3. patient with active internal bleeding 4. Impossible to anticoagulation or antiarrhythmic drug 5. valvular atrial fibrillation (Mitral stenosis > grade II, Mechanical valve, Mitral valve replacement) 6. LVEF(left ventricular ejection fraction ) < 30% 7. Structural heart disease requiring surgical correction 8. The patients who had been performed catheter ablation of atrial fibrillation or heart surgery 9. Patients who are already on antiarrhythmic drug for rhythm control 10. Patients with severe medical disease 11. Expected survival < 1 year 12. Patients with invasive surgery or surgery scheduled 13. Severe alcoholics, drug addiction 14. A patient against MRI(magnetic resonance imaging) scanning 15. pregnancy 16. A patient participating in another study 17. Patients judged to be unfit for clinical trial by researchers' judgment
Healthy Volunteers

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Major cardiovascular or overall death, such as cerebral infarction, myocardial infarction, sudden death, and death, that occurred during follow-up.
Timepoint	Follw up at 2 weeks, 2 months, 6, 12, 18, 24 months
Secondary Outcome(s) 1
Outcome	Reoccurrence of atrial fibrillation as evidenced by electrocardiogram and changes in echocardiography heart rate variability during post-procedure follow-up
Timepoint	Follw up at 2 weeks, 2 months, 6, 12, 18, 24 months

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Not provided at time of Registration

Move list page Move to top