Rhythm Control of AF in Patients With Acute Stroke

Atrial Fibrillation Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02285387
• Other study ID #: 4-2014-0728
• Status: Recruiting
• Phase: N/A
• Start date: November 2014
• Est. completion date: August 2019

Study information

• Verified date: March 2019
• Source: Yonsei University
• Contact: Hui-Na Pak, MD
• Phone: 82-2-2228-8459
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Rhythm control
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
• Rate control
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.

Locations

Country	Name	City	State
Korea, Republic of	Severance Cardiovascular Hospital, Yonsei University Health System	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year
Primary	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	1 year
Primary	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	1 year