Rhythm Control of AF in Patients With Acute Stroke

March 25, 2019 updated by: Yonsei University

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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Recruiting
        • Severance Cardiovascular Hospital, Yonsei University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Rhythm control group
  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
Procedure: 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
ACTIVE_COMPARATOR: Rate control group
  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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
acute stroke with AF
Time Frame: 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
1 year
recurrence of silence stroke
Time Frame: 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
1 year
recurrence of AF after rhythm control
Time Frame: 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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (ANTICIPATED)

August 1, 2019

Study Completion (ANTICIPATED)

August 1, 2019

Study Registration Dates

First Submitted

October 31, 2014

First Submitted That Met QC Criteria

November 3, 2014

First Posted (ESTIMATE)

November 7, 2014

Study Record Updates

Last Update Posted (ACTUAL)

March 26, 2019

Last Update Submitted That Met QC Criteria

March 25, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2014-0728

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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