Rhythm Control of AF in Patients With Acute Stroke

Yonsei University

Status: Unknown

Conditions: Atrial Fibrillation

Treatments: Procedure: Rhythm control; Procedure: Rate control

Study type: Interventional

Funder types: Other

Identifiers

NCT02285387

4-2014-0728

Details and patient eligibility

About

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)

Enrollment: 300 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

13. Contraindication to MRI 15. Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Rhythm control group

Experimental group

Description:

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

Treatment:

Procedure: Rhythm control

Rate control group

Active Comparator group

Description:

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.

Treatment:

Procedure: Rate control