NCT02633774

Brief Summary

Atrial fibrillation (AF) is associated with impaired cognitive function (CogF) and/or dementia, but it is unclear whether rhythm control of AF improves CogF or brain perfusion. The hypothesis is rhythm control of AF improves CogF by increasing brain perfusion with hemodynamic amelioration compared to AF state. We will randomize the patients with persistent AF to rhythm control group and rate control group, and check baseline and 3rd month cognitive function (K-MOCA score) and brain perfusion CT. K-MOCA score and brain perfusion CT findings will be compared between rhythm control group and rate control group of persistent AF.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 7, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 17, 2015

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

January 28, 2019

Status Verified

January 1, 2019

Enrollment Period

5 years

First QC Date

December 7, 2015

Last Update Submit

January 25, 2019

Conditions

Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

  • K-MOCA(Korean version of Montreal Cognitive Assessment)

    12 months after the enrollment

  • Brain perfusion CT

    12 months after the enrollment

Study Arms (2)

Rhythm control group

ACTIVE COMPARATOR

1\. Start AAD right after evaluating for LA size, EF, LA thrombus, and presence of CAD during anticoagulation 2. check the echo, brain perfusion CT and K-MOCA on baseline 3. confirm a thrombus through the TEE 4. Cardioversion after 1 month 5. Rhythm FU schedule (2012 ACC/AHA/ESC guidelines) 6. If AF recur, RFCA 7. check the brain perfusion CT, K-MOCA after 3M and 12M

Drug: Propafenone

Rate control group

ACTIVE COMPARATOR

1\. No AAD, just anticoagulation 2. HR control between 60\~110bpm (with beta blocker, calcium channel blocker, digoxin) 3. check the echo, brain perfusion CT and K-MOCA on baseline 4. check the brain perfusion CT and K-MOCA after 3M and 12M 5. Without the treatment about antiarrythmia and rhythm control, diffication of rate control, the subject will be drop out for study.

Drug: Apixaban

Interventions

PropafenoneDRUG

AAD(antiarrhythmic drug)

Rhythm control group
ApixabanDRUG

anti-coagulation

Rate control group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with persistent Atrial fibrillation (20\~80 years old)
  • LA diameter \< 55mm
  • patients possible to anticoagulation and anti arrhythmic drug

You may not qualify if:

  • Structural cardiac disease
  • Contraindication to brain perfusion CT
  • Catheter ablation history for AF, Cardiac surgery
  • active internal bleeding
  • Impossible to anticoagulation or antiarrhythmic drug
  • valvular AF ((MA\> GII, Mechanical valve, Mitral valve replacement)
  • LVEF \< 30%
  • With severe medical disease
  • Expected survival \< 1 year
  • Severe alcoholics, drug addiction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Cardiovascular Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Propafenoneapixaban

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Central Study Contacts

Hui-Nam Park, MD, Ph.D

CONTACT

82-2-2228-8459hnpak@yuhs.ac

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2015

First Posted

December 17, 2015

Study Start

November 1, 2015

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

January 28, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)