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Rhythm Control of AF in Patients With Acute Stroke

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02285387
Enrollment
300
Registered
2014-11-07
Start date
2014-11-30
Completion date
2019-08-31
Last updated
2019-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

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)

Interventions

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

PROCEDURERate 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.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
acute stroke with AF1 yearLong 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 stroke1 yearAdverse 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 control1 yearAdverse 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

Countries

South Korea

Contacts

Primary ContactHui-Na Pak, MD
82-2-2228-8459

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026