CTRI/2013/12/004238Other3 期
An open, multicentric prospective clinical trial to evaluate the efficacy and safety of Ibutilide fumarate injection in the treatment of Atrial Fibrillation or Flutter.
试验速览
- 阶段
- 3 期
- 状态
- Other
- 入组人数
- 120
- 试验地点
- 5
- 主要终点
- Proportion of patients achieving cardio version after intravenous administration of Ibutilide.
研究概览
简要总结
An open, multicentric prospective clinical trial toevaluate the efficacy and safety of Ibutilide fumarate injection in the treatmentof Atrial Fibrillation or Flutter.
Theaim of the study is to establish efficacy and safety of Ibutilide fumarate inthe treatment of Atrial Fibrillation or Flutter in Indian patients
120 adult Indian patients with AtrialFibrillation or Flutter will be enrolled in this study. Enrollment willcontinue until 100 evaluable subjects with Atrial Fibrillation or Fluttercomplete the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Above 18 yrs of age, with no previous exposure to investigational drug.
- •2.Weighing > 60 kg 3.Patients with sustained Atrial Fibrillation or Flutter lasting for >1hr to <60 days.
- •4.Patients developing Atrial Fibrillation or Flutter post cardiac surgery (1-7 days after surgery).
- •5.Corrected QT interval (QTc) ≤440 ms on a 12 lead electrocardiogram (ECG).
- •6.Haemodynamic stability (systolic blood pressure ≥90 mm Hg and diastolic blood pressure ≥60 mm Hg and < 105 mm Hg).
- •7.Ventricular rate >60bpm.
排除标准
- •1.History of Hyperthyroidism.
- •2.Heart Rate <60 bpm.
- •3.History or evidence of unstable angina pectoris, bronchospastic disease or myocardial infarction.
- •4.Known sinus node dysfunction, second or third degree atrioventricular (AV) block, bundle branch block, Wolff-Parkinson-White syndrome and/or torsade de pointes.
- •5.Concurrent treatment with verapamil, diltiazem, or drugs that prolong the QT interval 6.Recent major hemorrhage (within 6 months).
- •7.Coagulopathy 8.Pregnant or breast feeding 9.Acute congestive heart failure 10.Hypokalemia or hyperkalemia (Electrolyte abnormalities) 11.Polymorphic ventricular tachycardia secondary to antiarrhythmic class III and class I 12.Left ventricular ejection fraction < 40% 13.Serum creatinine levels >2.5mg/dL 14.Liver function test > 2 times the upper limit of normal value 15.History of chronic renal failure or a creatinine clearance of < 30ml/min.
- •16.Known hypersensitivity to investigational drug or its components.
结局指标
主要结局
Proportion of patients achieving cardio version after intravenous administration of Ibutilide.
时间窗: 72 hours
次要结局
- Adverse events observed during the treatment period(72 hours)
研究者
研究点 (5)
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