Arrhythmias & electrophysiologyRandomised controlled trial
Flecainide acetate inhalation solution for cardioversion of recent-onset, symptomatic atrial fibrillation: results of the phase 3 RESTORE-1 trial
- Randomised controlled trial
- multicentre
- double-blind
- placebo-controlled
- stopped prematurely
- Trial stopped prematurely after treating 55 patients
Authors' conclusion
Despite early termination of the trial, FlecIH-103 was significantly more effective than placebo in cardioverting AF. Safety data did not show any serious AEs.
Study context
- Population
- Patients with symptomatic, recent-onset (≤48 h) paroxysmal atrial fibrillation (AF)treated
- Participants
- 55 patients
- Comparison
- Inhaled flecainide acetate vs placebo
- Primary endpoint
- Conversion of AF
Primary result
As reported in the abstract
Conversion rate
P = 0.04
Further findings
| Outcome | Values |
|---|---|
| Flecainide plasma level (active group) | FlecIH-103 mean 198 (SD 156) ng/mL |
- Flecainide plasma level (active group): ∼50% lower than in the previous studies
Time to conversion
- Median time to conversion
- 12.8 min (IQR: 17.2)
Safety
Adverse events
- Most common adverse events (AEs): dysgeusia, dyspnoea, cough; all short-lasting, mild or moderate; no serious AEs
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Flecainide acetate inhalation solution for cardioversion of recent-onset, symptomatic atrial fibrillation: results of the phase 3 RESTORE-1 trial. Europace. Published 25 March 2025. doi:10.1093/europace/euaf064
Summarised from the published abstract; every number is checked against it