An open, multicentric prospective clinical trial to evaluate the efficacy and safety of Ibutilide fumarate injection in the treatment of Atrial Fibrillation or Flutter.

Zuventus Healthcare Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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

•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.

发起方