Rhythm Control of AF in Patients With Acute Stroke

NCT ID: NCT02285387

Last Updated: 2019-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2019-08-31

Brief Summary

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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)

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rhythm control group

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

Group Type EXPERIMENTAL

Rhythm control

Intervention Type PROCEDURE

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

Rate control group

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.

Group Type ACTIVE_COMPARATOR

Rate control

Intervention Type PROCEDURE

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.

Interventions

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Rhythm control

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

Intervention Type PROCEDURE

Rate control

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance Cardiovascular Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hui-Na Pak, MD

Role: CONTACT

82-2-2228-8459

Facility Contacts

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Hui-Nam Pak, M.D., Ph.D.

Role: primary

82-2-2228-8459

References

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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.

Reference Type DERIVED
PMID: 35043663 (View on PubMed)

Other Identifiers

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4-2014-0728

Identifier Type: -

Identifier Source: org_study_id

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