Rhythm Control of AF in Patients With Acute Stroke

Not Applicable

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Rate control; Procedure: Rhythm control

• Registration Number: NCT02285387
• Lead Sponsor: Yonsei University

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-31
• Study Start: 2014-11
• Study First Submitted QC: 2014-11-03
• Study First Posted: 2014-11-07
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-03-26
• Primary Completion: 2019-08
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

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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

13. Contraindication to MRI 15. Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rate control group	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.
Rhythm control group	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

Primary Outcome Measures

Name	Time	Method
acute stroke with AF	1 year	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	1 year	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	1 year	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

Trial Locations

Locations (1)

Severance Cardiovascular Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of