What is the clinical evidence from this study?

Study design: RCT. Population: Paroxysmal atrial fibrillation (n=80). Intervention: Antazoline vs. Placebo (0.9% saline). Primary outcome: Conversion of atrial fibrillation to sinus rhythm confirmed in standard 12-lead ECG during the observation period.

September 11, 2012TrialsOpen Access

Clinical efficacy of antazoline in rapid cardioversion of paroxysmal atrial fibrillation -- a protocol of a single center, randomized, double-blind, placebo-controlled study (the AnPAF Study)

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Key result

Intravenous antazoline will be evaluated for its clinical efficacy in the rapid cardioversion of paroxysmal atrial fibrillation compared to placebo in a planned randomized trial of 80 patients.

Why the study?

Does intravenous antazoline improve the rapid conversion of paroxysmal atrial fibrillation to sinus rhythm compared to placebo in patients without advanced heart failure or significant valvular disease?

Study Design

Type

RCT (n=80)

Blinding

Double-blind

Randomization

Permuted block randomization

Multicenter

Structured PICO

Population

A planned trial of 80 patients aged 40 to 75 years with paroxysmal atrial fibrillation lasting less than 43 hours, without significant valvular disease or advanced heart failure.

Intervention

Antazoline administered intravenously in boluses of 50 mg diluted to 10 cm3 every five minutes up to a cumulative dose of 250 mg or conversion of AF to sinus rhythm.

Comparator

0.9% saline (placebo) administered intravenously in boluses of 10 cm3 every five minutes up to a cumulative volume of 50 cm3 or conversion of AF to sinus rhythm.

Outcome

Conversion of AF to sinus rhythm confirmed in standard 12-lead ECG during the 1.5-hour observation period.surrogate

This study protocol outlines a randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of intravenous antazoline for the rapid cardioversion of paroxysmal atrial fibrillation.

Limitations

Single center design
Presumed lack of statistical power for secondary and safety endpoints

Discussion

No takes yet. Share an insight, caveat, or question.

Implication

IV antazoline unproven for paroxysmal AF cardioversion; planned RCT will deliver first placebo-controlled efficacy data.

Cite This Study

Farkowski et al. (2012) conducted an RCT in Paroxysmal atrial fibrillation (n=80). Antazoline vs. Placebo (0.9% saline) was evaluated on Conversion of atrial fibrillation to sinus rhythm confirmed in standard 12-lead ECG during the observation period. Intravenous antazoline will be evaluated for its clinical efficacy in the rapid cardioversion of paroxysmal atrial fibrillation compared to placebo in a planned randomized trial of 80 patients.

synapsesocial.com/papers/6a988ca5df83a7cad376b07b https://doi.org/10.1186/1745-6215-13-162

Topics

Persistent AF management Atrial fibrillation Anticoagulation in AF AF ablation outcomes

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Bookmark

Clinical efficacy of antazoline in rapid cardioversion of paroxysmal atrial fibrillation -- a protocol of a single center, randomized, double-blind, placebo-controlled study (the AnPAF Study)

Study Design

Structured PICO

Limitations

Discussion

Implication

Cite This Study

Topics

Clinical efficacy of antazoline in rapid cardioversion of paroxysmal atrial fibrillation -- a protocol of a single center, randomized, double-blind, placebo-controlled study (the AnPAF Study)

Study Design

Structured PICO

Limitations

Discussion

Implication

Cite This Study

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