NL-OMON50703已完成2 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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 164
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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 Self-Administration (Patient-Led) Cardioversion Study only:
- •Subjects whose AF converts to SR with inhaled flecainide and without serious
- •AE(s) or complications in Part A, Part B, or the Medically-Led Cardioversion
- •Study of Part C.
- •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)
- •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.
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 > 150 bpm. For
- •subjects to meet eligibility criteria, at least 2 of the 3 measurements of
- •vital signs during screening (45, 30, and/or 15 minutes prior to dosing) must
- •meet criteria.
- •3) Current AF episode has been 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 (including the
- •study drug to be
- •administered in this study) does not exceed 320 mg within a 24-hour period, per
- •standard of care.
- •Relevant structural heart disease
- •4) History of acute decompensated heart failure (HF)
- •5) History within 6 months prior to screening of, or present HF with abnormal
- •left ventricular ejection fraction (LVEF), and/or Class II or higher HF as
- •defined by the New York Heart Association (NYHA) (see details under Section
- •20.1), and/or medication history suggestive of HF, in the opinion of the
- •Investigator. If participating in the optional Handheld Echo Sub-Study, the
- •subject must have a LVEF * 45%, absent or mild left ventricular hypertrophy,
- •and absent or mild valvular disease (stenosis or regurgitation)
- •6) Evidence of current ongoing myocardial ischemia, such as signs (e.g.,
- •significant [e.g., > 2 mm] ST segment elevation or depression on ECG,
- •echocardiographic findings suggestive of acute myocardial infarction) and/or
- •symptoms (e.g., angina pectoris, atypical angina pectoris), and/or being
- •medicated with anti-anginal medication. In addition, subjects with signs of
- •prior myocardial infarction (such as pathological Q waves) who are also taking
- •concomitant medications for angina
- •pectoris should be evaluated for presence of ongoing ischemia.
- •7) History of myocardial infarction (MI) within 3 month of screening
- •8) Known uncorrected severe aortic or mitral valve stenosis
- •9) Known hypertrophic cardiomyopathy with outflow tract obstruction, Other
- •cardiac conditions
- •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
- •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
- •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 pause (e.g., >3 seconds) and/or slow ventricular rhythm (e.g.,
- •<45 bpm) or ventricular pause (e.g., >3 seconds) at time of conversion
- •Note: Sinus node dysfunction in AF is more prevalent
- •d) Brugada Syndrome
- •e) Torsades de pointes (TdP)
- 另有 5 项未显示
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