Trial | NCT02145546  Report issue

Official Title

Antiarrhythmic Drugs Assessment in Preventing Atrial Fibrillation

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    600
The current evidences indicate that ~30% patients with sick sinus syndrome(SSS) would develop persistent atrial fibrillation (AF) after a long term pacing therapy. However, the accurate influence of antiarrhythmic drugs on the AF is still not well defined. The purpose of the study is to assess the therapeutic effects of various antiarrhythmic drugs (Amiodarone, Sotalol and Propafenone) on the long term management of AF in SSS patients with AF, including the reduced AF burden (duration and episodes) and persistent AF free survival rate. All patients will be followed up for 12 months.
Study Started
May 31
2014
Primary Completion
May 31
2017
Anticipated
Study Completion
May 31
2017
Anticipated
Last Update
May 23
2014
Estimate

Drug Amiodarone

Amiodarone: 200mg three times a day for two weeks, then change to 200mg per day for the rest of the study.

  • Other names: cordarone, pacerone, aratac, arycor, atlansil, tachyra

Drug Propafenone

150mg per 8 hours, 3 times per day

  • Other names: rythmol SR, rytmonorm

Drug Sotalol

80mg twice per day.

  • Other names: betapace, betapace AF, sotalex, sotacor

Amiodarone Experimental

Patient will take Amiodarone orally

Sotalol Experimental

Patients will take sotalol orally

Propafenone Experimental

Patients will take propafenone orally

Control No Intervention

Patients will take no antiarrhythmic drugs except β-blocker

Criteria 

Inclusion Criteria:

at least 18 years old
sick sinus syndrome with pacemaker Class I or Class IIa indication
has a pacemaker which can provide the daily AF burden monitor record for at least 28 days

has at AF record in the past 6 months, the valid AF record includes any of

at least one 30 seconds AF holter record
at least one 15 seconds 12-ECG record
at least 5 minutes long AF episodes record from pacemakers
able and willing to give informed consent

Exclusion Criteria:

will have cardiac surgery in the next 6 month or in the waiting list of heart transplantation
NYHA Class III or IV
LVEF <50%
Reversible AF, such as AF caused by hyperthyroidism or severe postoperative atrial fibrillation
Persistence AF
Expected life expectancy less than 1 year
Planned to be pregnant or be in the feeding period in the next year
Non-stable, decompensated heart failure
Allergy to Amiodarone, Propafenone or Sotalol
Cancer
Clear liver damage ( ALT and/or AST > 2*normal limit)
Patients with cardiogenic shock history
Be in the treatment of Amiodarone for more than 3 months or less than 3 months with Amiodarone wash out period less than 30 days
Coronary artery disease (CHD), cardiomyopathy, severe valvular heart disease, severe obstructive pulmonary disease (COPD), long QT syndrome
No Results Posted