Flecainide Acetate Inhalation Solution for Cardioversion of Recent-Onset, Symptomatic Atrial Fibr… (NCT05039359) | Clinical Trial Compass
TerminatedPhase 3
Flecainide Acetate Inhalation Solution for Cardioversion of Recent-Onset, Symptomatic Atrial Fibrillation
Stopped: Limited efficacy upon blinded review
United States54 participantsStarted 2022-04-26
Plain-language summary
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical study designed to evaluate the efficacy and safety of FlecIH-103 (flecainide acetate inhalation solution) compared with placebo in patients with recent-onset, symptomatic newly diagnosed or paroxysmal AF. Approximately 400 patients are expected to be enrolled in this study. Patients will be randomized 3:1 to receive FlecIH-103 at a total dose of up to 120 mg estimated total lung dose (eTLD) (n=300) or placebo inhalation solution (n=100). Randomization will be stratified by geographic region (US and ex-US) and duration of symptoms of the current AF episode (≥1 hour to ≤24 hours and \>24 hours to ≤48 hours).
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. ≥18 and ≤85 years of age
✓. Recent onset of symptomatic newly diagnosed or paroxysmal AF
✓. Recent onset is defined as a symptom duration ≥1 and ≤48 hours at time of dosing
✓. Newly diagnosed AF is AF that has not been diagnosed previously, independent of its duration
✓. Paroxysmal AF is defined as recurrent AF in a patient whose previous AF episode(s) self-terminated (ie, without treatment) or terminated with intervention ≤7 days of onset.
✓. A symptomatic recent-onset AF episode post cardiac ablation for paroxysmal AF would be considered eligible
Exclusion criteria
✕. History of non self-terminating AF/AFL as defined by
✕. One or more failed attempts to restore SR with pharmacological therapy
✕. ECV procedure for an AF episode ≤1 year prior to screening. Exception: One (1) prior ECV is allowed if no option for pharmacological conversion was previously available
What they're measuring
1
Assessment of proportion of patients whose AF converts using continuous ECG monitoring
✕. More than 3 ECV procedures in ≤5 years prior to screening
✕. Current diagnosis of persistent AF
✕. Persistent AF defined as AF that is continuously sustained \>7 days, including episodes terminated by cardioversion (drugs or electrical cardioversion) after \>7 days. Patients with persistent AF do not have self-terminating AF episodes
✕. Patients who have undergone an ablation procedure for persistent AF are not eligible
✕. One or more episodes of AFL ≤6 months prior to randomization