Flecainide Acetate Inhalation Solution for Cardioversion of Recent-Onset, Symptomatic Atrial Fibrillation

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Paroxysmal Atrial Fibrillation

In brief

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).

Key facts

Study ID

NCT05039359

Run by

InCarda Therapeutics, Inc.

People needed

54

Starts

2022-04-26

Expected to finish

2023-05-22

Last updated by the study team

2023-10-30

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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

You may not qualify if…

• 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
• 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
• a. Exception: a patient who has received ablation for AFL ≤3 months prior to screening with no recurrence of AFL prior to randomization is considered eligible Vital signs
• Hemodynamic or cardiac instability during AF, defined as any of the following:
• Systolic blood pressure <100 or ≥160 mmHg
• Diastolic blood pressure ≥95 mmHg
• Ventricular heart rate <80 or >160 bpm
• Respiratory rate >22 breaths per minute Relevant structural heart disease
• History of decompensated heart failure (HF)
• Evidence of significant HF defined as any of the following:
• a. Hospitalization in the last 12 months for HF or suspected HF event b. Most recent assessment of left ventricular ejection fraction (LVEF) <45% i. For patients in the United States, a standard diagnostic echocardiogram assessed ≤180 days prior to screening is required to ascertain eligibility. If none is available, the patient must undergo a standard diagnostic echocardiogram or a diagnostic echocardiogram using a portable ultrasound device (handheld echocardiogram [HHE]) during screening to confirm eligibility c. New York Heart Association (NYHA) Class II-IV symptoms d. Medication history suggestive of HF per the Investigator's discretion
• Signs or symptoms of ongoing myocardial ischemia, including any of the following:
• Significant ST segment elevation or depression (ie, ≥2 mm) on a standard 12-lead ECG
• Echocardiogram findings (eg, wall motion abnormalities) suggestive of acute myocardial infarction (MI)
• Angina pectoris, atypical angina pectoris, or receiving antianginal medication for ischemia
• History of MI ≤3 months of screening
• History of uncorrected moderate or severe aortic or mitral valvular stenosis, in the opinion of the Investigator
• a. If an echocardiogram is performed at screening, moderate or severe valve disease observed during the examination is considered exclusionary
• History of LV hypertrophy with LV thickness >12 mm as observed in the most recent assessment, ie, an echocardiogram Other CV conditions

Where it is running

• UC Davis Medical Center — Davis, California, United States
• Memorial Care — Long Beach, California, United States
• Bridgeport Hospital — Bridgeport, Connecticut, United States
• Orlando Health Heart and Vascular Institute and Orlando Regional medical Center — Orlando, Florida, United States
• Tampa General Hospital; Center of Research Excellence — Tampa, Florida, United States
• IU Health Ball Memorial Hospital — Muncie, Indiana, United States
• Reid Physician Associates — Richmond, Indiana, United States
• North Kansas City Hospital — Kansas City, Kansas, United States
• University of Kansas Medical Center Research Institute — Kansas City, Kansas, United States
• Saint Michaels Medical Center — Newark, New Jersey, United States
• The Valley Hospital, Inc — Ridgewood, New Jersey, United States
• Mount Sinal Hospital — New York, New York, United States
• Weill Cornell Medical Center — New York, New York, United States
• University of Cincinnati College of Medicine — Cincinnati, Ohio, United States
• The MetroHealth System — Cleveland, Ohio, United States
• Cleveland Clinic Emergency Department — Cleveland, Ohio, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• Reading Hospital — Reading, Pennsylvania, United States
• EDUMED s.r.o. — Náchod, Czechia
• Nemocnice Slany — Slaný, Czechia
• DPC Hospital Egyesitett Szent Istvan es Szent Laszlo Korhaz — Budapest, Hungary
• University of PACs — Pécs, Hungary
• Deventer Ziekenhuis — Deventer, Netherlands
• Ziekenhuis Gelderse Vallei — Ede, Netherlands
• Admiraal de Ruyter Ziekenhuis — Goes, Netherlands

Full record on ClinicalTrials.gov

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