CTRI/2018/01/011248已完成4 期
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 - IBUTILIDE PHASE IV
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
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) ââ?°Â¤ 440 ms on a 12 lead electrocardiogram (ECG).
- •Haemodynamic stability ( systolic blood pressure ââ?°Â¥ 90 mm Hg and diastolic blood pressure ââ?°Â¥ 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.
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