Dataset Information

Randomised double blind trial of oral versus intravenous flecainide for the cardioversion of acute atrial fibrillation.

ABSTRACT:

Objective

To investigate whether an oral loading dose of flecainide is as safe and effective as intravenous flecainide for the cardioversion of acute atrial fibrillation.

Design

Prospective, randomised, double blind, double placebo study.

Setting

Cardiac care unit of a large district general hospital in the UK.

Patients and methods

79 patients presenting with symptomatic acute atrial fibrillation: patients were given either intravenous flecainide (n = 39) or a solution of oral flecainide (n = 40), with appropriate placebos. All patients were heparinised during the study.

Primary outcome measures

Safety; mean time to cardioversion; proportion of patients restored to sinus rhythm at two hours and eight hours after treatment. Analysis was by intention to treat.

Results

There were no differences in baseline characteristics between the oral and intravenous groups. Both forms of flecainide were well tolerated, with no adverse clinical events during the study. The mean time to cardioversion was 110 minutes in the oral group and 52 minutes in the intravenous group (p = 0.002). Two hours after treatment, 27 of the 40 patients in the oral group (68%) and 25 of the 39 in the intravenous group (64%) had reverted to sinus rhythm (p = 0.74). Eight hours after treatment, 30 patients in the oral group (75%) and 28 in the intravenous group (72%) had reverted to sinus rhythm (p = 0.76).

Conclusions

Intravenous flecainide restored sinus rhythm more rapidly than oral flecainide, but at two hours and eight hours after treatment there was no difference in the proportion of patients cardioverted by the two approaches. These results suggest a role for oral loading doses of flecainide in the treatment of acute or symptomatic paroxysmal atrial fibrillation.

SUBMITTER: Alp NJ

PROVIDER: S-EPMC1729414 | biostudies-literature | 2000 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Randomised double blind trial of oral versus intravenous flecainide for the cardioversion of acute atrial fibrillation.

Alp N J NJ Bell J A JA Shahi M M

Heart (British Cardiac Society) 20000701 1

<h4>Objective</h4>To investigate whether an oral loading dose of flecainide is as safe and effective as intravenous flecainide for the cardioversion of acute atrial fibrillation.<h4>Design</h4>Prospective, randomised, double blind, double placebo study.<h4>Setting</h4>Cardiac care unit of a large district general hospital in the UK.<h4>Patients and methods</h4>79 patients presenting with symptomatic acute atrial fibrillation: patients were given either intravenous flecainide (n = 39) or a soluti ...[more]

PMID: 10862585

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Project description:BackgroundRapid conversion of atrial fibrillation (AF) to sinus rhythm may be achieved by the administration of class IA, IC and III antiarrhythmic drugs or vernakalant hydrochloride. However, that treatment may be related to potential pro-arrhythmia, lack of efficacy or the exceptionally high cost of a compound used. Antazoline is a first generation antihistaminic agent with chinidin-like properties. When administered intravenously, antazoline exerts a strong antiarrhythmic effect on supraventricular arrhythmia, especially on AF, facilitating rapid conversion to sinus rhythm. Despite a relative lack of published data antazoline has been marketed in Poland and widely used in cardiology wards and emergency rooms for many years due to its efficacy, safety and rapid onset of action within minutes of administration.Methods/designA randomized, double blind, placebo-controlled, superiority clinical trial was designed to assess clinical efficacy of antazoline in rapid conversion of AF to sinus rhythm. Eligible patients will present AF lasting less than 43 hours, will be in stable cardio-pulmonary condition and will have no prior history of advanced heart failure or significant valvular disease. Long-term antiarrhythmic therapy is not considered an exclusion criterion. Subjects who fulfill selection criteria will be randomly assigned to receive intravenously either antazoline or placebo in divided doses and observed for 1.5 hours after conversion to sinus rhythm or after the last i.v. bolus. Primary end point will be the conversion of AF to sinus rhythm confirmed in an electrocardiogram (ECG) during the observation period. Secondary end points will be comprised of time to conversion and return of AF during the observation period. Special consideration will be given to the observation of any adverse events. A sample size of 80 patients was calculated based on the following assumptions: two-tailed test, a type I error of 0.01, a power of 90%, efficacy of placebo 5%, efficacy of antazoline 50% and 20% drop-out rate to fulfill the criteria of intention-to-treat analysis. Due to the presumed lack of statistical power, the secondary end points and safety endpoints will be considered exploratory.Clinical trials registryClinicalTrials.gov, NCT01527279.

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Dataset Information

Randomised double blind trial of oral versus intravenous flecainide for the cardioversion of acute atrial fibrillation.

Objective

Design

Setting

Patients and methods

Primary outcome measures

Results

Conclusions

Publications

Randomised double blind trial of oral versus intravenous flecainide for the cardioversion of acute atrial fibrillation.

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