NCT01259622终止2 期
A mulTi-center, Randomized, doUble-bliNded, Placebo-controlled Dose-escalating Study of the Effects of K201 on the RestorAtion of Sinus Rhythm in Subjects With Symptomatic Atrial Fibrillation of Recent Onset
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 80
- 主要终点
- proportion of subjects who convert to sinus rhythm
研究概览
简要总结
The purpose of this study is to evaluate the effects of a single intravenous infusion of K201 compared to placebo in a dose escalating manner on conversion to sinus rhythm, reduction of subject's symptom score, and safety.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Symptomatic atrial fibrillation for more than 3 hours and less than 7 days (as dated by symptoms).
- •Atrial fibrillation documented by ECG at the start of study drug infusion.
排除标准
- •Previous exposure to K201
- •QTcF (Fridericia correction) >440 ms
- •QRS interval > 140 ms
- •Paced atrial or paced ventricular rhythm on ECG
- •History of receiving another intravenous Class I or Class III antiarrhythmic drug within 3 days of randomization
- •History of amiodarone (oral or IV) in the last 3 months.
- •Clinical evidence or history of acute coronary syndrome (e.g. myocardial infarction, unstable angina) within 30 days prior to randomization
- •History of failed electrical cardioversion at any time in the past
- •History of polymorphic ventricular tachycardia (e.g. torsades des pointes)
- •History or family history of Long QT Syndrome
- •History of ventricular tachycardia requiring drug or device therapy
- •Ejection fraction of 40% or less.
研究组 & 干预措施
placebo
Placebo Comparator
干预措施: saline (Drug)
K201
Experimental
intravenous K201
干预措施: K201 (Drug)
结局指标
主要结局
proportion of subjects who convert to sinus rhythm
时间窗: 24 hours
次要结局
未报告次要终点
研究者
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