EUCTR2021-001627-40-CZ进行中（未招募）1 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of Flecainide Acetate Inhalation Solution for Cardioversion of Recent-Onset, Symptomatic Atrial Fibrillation to Sinus Rhythm - RESTORE-1
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
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. =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
排除标准
- •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) <100 or =160 mmHg
- •b) Diastolic blood pressure (DBP) =95 mmHg
- •c) Ventricular HR <80 or >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 <45%
- •c) New York Heart Association Class II-IV symptoms
- •d) Medication history suggestive of HF per the Investigator's discretion
- •8. Signs or symptoms of ongoing myocardial ischemia, including any of the following:
- •a) Significant ST segment elevation or depression (ie, =2 mm) on a standard 12-lead ECG
- •b) Echocardiogram findings (eg, wall motion abnormalities) suggestive of acute myocardial infarction
- •c) Angina pectoris, atypical angina pectoris, or receiving antianginal medication for ischemia
- •9. History of MI =3 months of screening
- •10. 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 valvular stenosis observed during the examination is considered exclusionary.
- •11. History of LV hypertrophy with LV thickness >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 <45 bpm at time of conversion
- •14. Any of the following ECG-related features at screening:
- •a) QT interval corrected for heart rate using the Fridericia formula (QTcF) >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 disea
研究者
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