An Open-Label, Multicentre, Prospective, Phase- IV Study to Evaluate the Efficacy and Safety of Ibutilide Fumarate Injection (0.1mg/ml) in the Treatment of Atrial Fibrillation and Flutter
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 7
- 主要终点
- To investigate the efficacy of Ibutilide for cardioversion of atrial fibrillation and flutter
研究概览
简要总结
An open label, multicentre, prospective phase- IV study to evaluate the efficacy and safety of Ibutilide fumarate injection (0.1mg/ml) in the treatment of Atrial Fibrillation and Flutter
The aim of this study is to establish the efficacy and safety of Ibutilide fumarate in the treatment of Atrial Fibrillation and Flutter in Indian patients.
120 adult Indian patients with Atrial Fibrillation or Flutter will be enrolled in this study
The study duration will be of 24 hours. Afteradministration of the required dose of Ibutilide, the patient will be observedin intensive care unit for 24 hours.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 19.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients >18 yrs of age Patients with sustained Atrial Fibrillation or Flutter lasting for >1hr to <90 days.
- •Patients developing Atrial Fibrillation or Flutter post cardiac surgery (1-7 days after surgery).
- •Corrected QT interval (QTc) ≤ 440 ms on a 12 lead electrocardiogram (ECG).
- •Haemodynamic stability ( systolic blood pressure ≥ 90 mm Hg and diastolic blood pressure ≥ 60 mm Hg and < 105 mm Hg).
- •Absence of structural heart disease Ventricular rate >60bpm.
排除标准
- •Known hypersensitivity to ibutilide injection or its components like sulphonamides or sulfa drugs.
- •Known sinus node dysfunction, second or third degree atrioventricular (AV) block, bundle branch block and/or torsades de pointes.
- •Patient with documented evidence of atrial clot formation.
- •Severely Anaemic patients (Hb < 8.0 g/dL) Pregnant or breast feeding Grade III & IV congestive heart failure Serum potassium <3.5 mEq/L or serum magnesium <1.5 mEq/L Severe hepatic, hematologic, metabolic, renal, gastrointestinal, central nervous system, psychiatric, or other disorder that could interfere with the conduct of the study; or compromise safety.
结局指标
主要结局
To investigate the efficacy of Ibutilide for cardioversion of atrial fibrillation and flutter
时间窗: Proportion of patients achieving cardioversion (sinus rhythm) after intravenous administration of Ibutilide fumarate injection. | Mean Time to achieve cardioversion
次要结局
- To evaluate the safety of the Ibutilide in Indian patients(Proportion of patients who remained in sinus rhythm at 24 hours post dose)