Recent-onset symptomatic atrial fibrillation MedDRA version: 20.0 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Product Name: flecainide acetate
Product Code: FlecIH-103
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: Flecainide Acetate
CAS Number: 54143-56-5
Current Sponsor code: Flecainide Ace
Sponsors
InCarda Therapeutics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. =18 and =85 years of age 2. Recent onset of symptomatic newly diagnosed or paroxysmal AF a) Recent onset is defined as a symptom duration =1 and =48 hours at time of dosing b) Newly diagnosed AF is AF that has not been diagnosed previously, independent of its duration c) 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. d) A symptomatic recent-onset AF episode post cardiac ablation for paroxysmal AF would be considered eligible Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: 1. History of non self-terminating AF/atrial flutter: a) One or more failed attempts to restore SR with pharmacological therapy b) 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 c) More than 3 ECV procedures in =5 years prior to screening 2. Current diagnosis of persistent AF 3. One or more episodes of AFL =6 months prior to randomization 4. Hemodynamic or cardiac instability during AF, defined as at least 3 consecutive measurements of any of the following during screening: a) Systolic blood pressure (SBP) 160 bpm 5. Respiratory rate >22 breaths per minute 6. History of decompensated heart failure 7. 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 12 mm as observed in the most recent assessment, ie, an echocardiogram 12. Stroke (including transient ischemic attack) =3 months prior to randomization 13. History of any of the following cardiac abnormalities: a) Long QT syndrome b) Conduction system disease c) Brugada syndrome d) Torsade de pointes e) Diagnosed with sinus node dysfunction or any of the following: i. History of unexplained or cardiovascular syncope ii. Bradycardia suggestive of sinus node dysfunction iii. Prior electrical or pharmacological cardioversion associated with sinus or ventricular pause >3 seconds or ventricular heart rate 480 msec b) Wide QRS complex (ie, duration =120 msec) or history of documented wide QRS complex tachycardia (ie, wide QRS complex with ventricular heart rate >100 bpm) c) Presence of VT. Site telemetry should be equipped with an alarm system for VT and premature ventricular complexes (PVCs) or be continuously visually observed prior to dosing. 15. Presence of a pacemaker 16. Cardiac surgery for any of the exclusionary conditions (eg, valvular disease, hypertrophy, coronary artery disease) =6 months prior to randomization 17. Known severe renal impairment or patient receiving dialysis 18. Known abnormal liver function, including hepatic disease or biochemical evidence of significant liver derangement 19. Uncorrected hypokalemia 20. Uncorrected hypomagnesemia 21. Chronic obstructive pulmonary disease or other established pulmonary disease in need of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of flecainide acetate inhalation solution and placebo for the conversion of atrial fibrillation (AF) to sinus rhythm (SR) in patients with recent-onset, symptomatic newly diagnosed or paroxysmal AF ;Secondary Objective: To compare the effects of flecainide acetate inhalation solution and placebo on the time to conversion of AF to SR, AF-related symptoms, hospitalizations, AF-related interventions, and the time to discharge in patients with recent-onset, symptomatic newly diagnosed or paroxysmal AF;Primary end point(s): The proportion of patients whose AF converts to SR =90 minutes after initiation of dosing;Timepoint(s) of evaluation of this end point: =90 minutes after initiation of dosing | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) The time to conversion of AF to SR =90 minutes after initiation of dosing 2) The proportion of patients with AF-related symptoms at the 90 minute time point 3) The proportion of patients requiring hospitalization prior to discharge 4) The prevalence (ie, events per patient) of additional AF-related interventions required prior to discharge 5) The time to discharge-eligible status ;Timepoint(s) of evaluation of this end point: 1) =90 minutes after initiation of dosing 2) 90 minutes after initiation of dosing 3) prior to discharge 4) discharge-eligible status | — |
Countries
Canada, Czechia, Czech Republic, Hungary, Netherlands, Poland, Spain, United States
Contacts
Public ContactRESTORE-1 Study Lead
InCarda Therapeutics, Inc.
Outcome results
None listed