CompletedInterventionalPhase 3Updated Mar 15, 2019
Rhythm Control of AF in Patients With Acute Stroke | NCT02285387 | Trialant
Unknown statusInterventionalNot ApplicableUpdated Mar 26, 2019
Rhythm Control of AF in Patients With Acute Stroke
ClinicalTrials.gov ID
NCT02285387
Lead Sponsor
Yonsei UniversityOTHER
Overall Status
Unknown status
Study Type
Interventional
Phase
Not Applicable
Enrollment
300Estimated
Last Update Posted
Mar 26, 2019Actual
Start Date
Nov 2014
Primary Completion Date
Aug 2019Estimated
Completion Date
Aug 2019Estimated
Brief Summary
Prospective randomized (rhythm control or rate control) Objective of study
To analyze long term outcome of patients with acute stroke with atrial fibrillation according to the rhythm control
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)
Atrial Fibrillation
Rhythm control
Rate control
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with Atrial fibrillation (20~80 years old)
patients with Acute stroke within 7 days
LA diameter < 55mm
patients possible to anticoagulation and anti arrhythmic drug
NIHSS score ≤12
Exclusion Criteria:
Hemorrhagic transformation
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)
active internal bleeding
Impossible to anticoagulation or anti arrhythmic drug
Valvular AF (MA> GII, Mechanical valve, Mitral valve replacement)
LV ejection fraction < 30%
Structural cardiac disease
Catheter ablation history for AF, Cardiac surgery
Already prescribed anti arrhythmic drugs
With severe medical disease
Expected survival < 1year
Severe alcoholics, drug addiction
14. Contraindication to MRI 15. Pregnancy
Primary Purpose
Treatment
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
None (Open Label)
Hui-Na Pak, MDContact
82-2-2228-8459
Severance Cardiovascular Hospital, Yonsei University Health SystemRecruiting