EUCTR2018-000094-76-NL进行中（未招募）1 期
A prospective, randomized, multicenter study of flecainide acetate oral inhalation solution in single and repeat dose regimens for acute conversion to sinus rhythm (SR) in subjects with recent onset of symptomatic paroxysmal atrial fibrillation (AF). - INSTANT
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Subjects with recent-onset symptomatic AF at presentation.
- •2) With a duration at onset of symptoms from 1 hour to 48 hours
- •3) And from one of the following categories:
- •a) First detected episode of paroxysmal AF
- •b) Recurrent episode of paroxysmal AF
- •c) Episode post-cardiac ablation for paroxysmal AF
- •4)Part C Patient-Led Under Medical Supervision Cardioversion Study only: Subjects whose AF converted to SR with inhaled flecainide and without difficulties or issues with inhalation (in the opinion of the investigator), serious AE(s), or serious AESI(s) in Part A, Part B, or the Part C Medically-Led Cardioversion Study
- •NOTE: Subjects who:
- •- are prescribed a pill-in-the-pocket regimen (flecainide or propafenone) for paroxysmal AF, or
- •- are within 3 months of having undergone ablation of paroxysmal AF, or
- •- have experienced an episode of new AF but are not currently experiencing an episode of recent-onset
- •paroxysmal AF, or
- •- are known to have paroxysmal AF (or previously diagnosed with paroxysmal AF) and have one or
- •more previous symptomatic episodes but are not currently experiencing an episode of recent-onset
- •paroxysmal AF
- •may consent to pre-study screening prior to presenting with recent-onset symptomatic AF. These subjects will be eligible to receive study drug only when presenting with symptomatic paroxysmal AF of recent-onset (i.e., = 48 hours), consenting to the full study, and after meeting all eligibility criteria.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1) Subject < 18 or > 85 years of age
- •2) Hemodynamic and/or cardiac instability, with systolic blood pressure < 100 mmHg or > 150 mmHg, and/or ventricular heart rate < 80 bpm or > 160 bpm. must meet criteria.
- •3) Current AF episode treated with Class I or Class III antiarrhythmic drugs or electrical cardioversion. Subjects whose current AF episode has been treated with flecainide are eligible if their total cumulative exposure to flecainide does not exceed 320 mg within a 24-hour period, per site standard of care.
- •4) History of acute decompensated heart failure (HF)
- •5)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%
- •ii)For subjects in the EU who are participating in the optional HHE Sub-Study, the subject must undergo an 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
- •6) Evidence of current ongoing MI, such as signs, symptoms, and/or being medicated with anti-anginal medication. In addition, subjects with signs of prior MI who are also taking concomitant medications for AP should be evaluated for presence of ongoing ischemia.
- •7) History of myocardial infarction (MI) within 3 months of screening
- •8) Known uncorrected severe aortic or mitral valve stenosis
- •9) Hypertrophic cardiomyopathy with outflow tract obstruction
- •10) Current diagnosis of persistent AF
- •11) One or more episodes of atrial flutter within 6 months prior to screening or atrial flutter at presentation, except subjects who received ablation for atrial flutter at least 3 months prior to screening and had no subsequent recurrence of atrial flutter prior to enrollment
- •12) History of any of the following heart abnormalities:
- •a) Long QT syndrome
- •b) Conduction disease (e.g. second- or third-degree heart block, bundle branch block)
- •c) Diagnosed with sinus node dysfunction (e.g., sick sinus syndrome) and/or one of the following:
- •(i) history of unexplained or cardiovascular syncope,
- •(ii) known bradycardia suggestive of sinus node dysfunction, and/or
- •(iii) prior electrical or pharmacological cardioversion associated with prolonged sinus or ventricular pause (e.g., >3 seconds) and/or slow ventricular rhythm (e.g., <45 bpm) at time of conversion
- •Note: Sinus node dysfunction in AF is more prevalent
- •in subjects >75 years old.2
- •d) Brugada Syndrome
- •e) Torsades de pointes (TdP)
- •13) Any of the following ECG-related features:
- •a) QTc interval > 480 msec at screening (estimated by the Fridericia’s formula1)
- •b) QRS duration = 120 ms or history of previous documented wide QRS tachycardia
- •c) Predominantly (i.e., > 30 %) paced heart rhythm
- •d) Ventricular tachycardia (VT, sustained or nonsustained), or excessive premature ventricular complexes (PVCs, > 20 multifocal PVCs per hour),
- •prior to dosing as per site telemetry. Site telemetry should be equipped with an alarm system for VT and PVCs or be continuously visually observed prior to dosing
- •14) Severe renal impairment (eGFR < 30 mL/min/1.73 m2) or on dialysis
- •15)Known medical history of abnormal liver function prior to enrollment
- •16) Uncorrected hypokalemia (defined as serum potassium < 3.6 mEq/L) at screening.
- •required as long as a value of = 3.6 mEq/L is documented at screening.
- •17) Subjects with established pulmonary disease in need of inhalation medication.
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