Clinical Efficacy of Antazoline in Rapid Cardioversion of Paroxysmal Atrial Fibrillation - a Single Centre, Randomized, Double-blind, Placebo-controlled Study (the AnPAF Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Conversion of AF to SN confirmed in standard 12-lead ECG during observation period after first iv bolus
研究概览
简要总结
The purpose of this randomized, double blind, placebo-controlled, superiority clinical trial was to assess clinical efficacy of antazoline in rapid conversion of atrial fibrillation during observation sinus rhythm.
详细描述
Antazoline is a first generation antihistaminic agent with chinidin-like properties. When administered intravenously, antazoline exerts a strong antiarrhythmic effect on supraventricular arrhythmia especially on atrial fibrillation (AF) facilitating rapid conversion to sinus rhythm. Despite relative lack of published data antazoline is marketed in Poland and widely used in cardiology wards and emergency rooms due to its efficacy, safety and rapid onset of action within minutes of administration.
To show superiority of antazoline over placebo a sample size of 80 patients was calculated based on following assumptions: two-tailed test, a type I error of 0.01, a power of 90%, efficacy of placebo 5%, efficacy of antazoline 50% and 20% drop-out rate to fulfill the criteria of intention-to-treat analysis. Due to presumed lack of statistical power the secondary end points and safety endpoints will be considered exploratory.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent for participating in the study and written standard version of informed consent for cardioversion accepted in Institute of Cardiology, Warsaw, Poland
- •Age above 18 and good general condition
- •Potassium level over 3.5 mmol/l
- •Stable cardio-pulmonary state on enrollment
- •In case of unclear history of heart failure or suspicion of impaired left ventricle function echocardiography is indicated prior to enrollment
- •A long-term antiarrhythmic drug therapy is allowed
排除标准
- •Lack of written informed consent
- •Antazoline allergy
- •AF related to significant valvular disease
- •Clinically significant heart failure or ejection fraction < 55%
- •Diastolic blood pressure (BP) < 100mmHg
- •History of significant bradyarrhythmia not treated with permanent pacemaker
- •QT prolongation over 440ms or QTc (Bazett's formula) over population norm
- •Tachycardia > 160'
- •Advanced liver or kidney failure
- •Acute coronary syndrome, coronary artery by-pass graft, stroke or transient ischemic attack within 30 days before enrollment
- •Preexcitation in ECG not treated by radiofrequency ablation of accessory pathway
- •Signs and symptoms of ischemia related to AF
- •An investigational drug used within 30 days before enrollment
- •Pregnancy or breast feeding
研究组 & 干预措施
Placebo
Any patient fulfilling the inclusion criteria will be prepared to pharmacological cardioversion in a standard way comprising of standard baseline 12-lead ECG, continuous ECG monitoring, periodic noninvasive blood pressure monitoring (BP) and iv line. After drug administration the patient will be observed for 1.5 hour after the last dose with exit ECG and BP measure taken at the end of observation. Further treatment of the patient depends on clinical state and follows appropriate clinical guidelines.
干预措施: 0.9% saline (Drug)
Antazoline
Any patient fulfilling the inclusion criteria will be prepared to pharmacological cardioversion in a standard way comprising of standard baseline 12-lead ECG, continuous ECG monitoring, periodic noninvasive blood pressure monitoring (BP) and iv line. After drug administration the patient will be observed for 1.5 hour after the last dose with exit ECG and BP measure taken at the end of observation. Further treatment of the patient depends on clinical state and follows appropriate clinical guidelines.
干预措施: antazoline (Drug)
结局指标
主要结局
Conversion of AF to SN confirmed in standard 12-lead ECG during observation period after first iv bolus
时间窗: 1.5 hour
次要结局
- Time to conversion of AF to SN(1.5 hour)
- Hot flush(1.5 hour)
- Arterial pressure < 90mmHg(1.5 hour)
- Nausea/ vomiting(1.5 hour)
- Chest pain(1.5 hours)
- Tachycardia >180'(1.5 hours)
- Sustained supraventricular arrhythmia other than AF(1.5 hour)
- Drowsiness(1.5 hour)
- Headache(1.5 hour)
- Return of AF during observation period(1.5 hour)
- Serious adverse event defined as every adverse event requiring hospitalization or prolonged observation(1.5 hour)
- Disturbances of atrio-ventricular conduction(1.5 hour)
- New complex ventricular arrhythmia(1.5 hour)
- Prolongation of QTc in ms (Bazett's formula) in comparison to baseline(1.5 hours)