NCT01067833终止2 期
A Pilot Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Centered Safety, Tolerability and Preliminary EffiCacy Study of K201 Oral for the Prevention of ATrial FIbrillation (AF) Recurrence in Subjects Post-Conversion From AF
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
- 300
- 主要终点
- proportion of subjects in sinus rhythm
研究概览
简要总结
To evaluate the safety, efficacy, and tolerability of 3 doses of K201 (oral) administered for up to 28 days in subjects with recent DC cardioversion to sinus rhythm from sustained symptomatic atrial fibrillation (AF duration >3 days and <6 months).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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 AF (sustained >3 days and <6 months) and clinically indicated for cardioversion;
- •Adequate anticoagulant therapy for cardioversion in accordance with standard practice as recommended by ACC/AHA/ESC guidelines or with local clinical practice;
- •Hemodynamically stable (90 mmHg < systolic blood pressure < 190 mmHg)at screening and on Day 1;
排除标准
- •Known prolonged QT syndrome or QTc interval of >0.500 sec at screening; familial long QT syndrome; previous Torsade de Pointes; ventricular fibrillation; or sustained ventricular tachycardia (VT);
- •QRS >0.130 sec;
- •Previous episodes of second- or third-degree atrioventricular block;
- •Unsuccessful DC cardioversion attempt within 3 months; prior ablation for AF;
- •Persistent bradycardia with ventricular rate below 50 beats/min, sick-sinus syndrome or pacemaker (including CRT, AICD);
- •Myocardial infarction (MI), cardiac surgery, angioplasty, unstable angina or acute coronary syndrome within 30 days prior to entry into the study;
- •NYHA Class III or Class IV heart failure (HF) at screening or admission, or hospitalized for HF in previous 6 months;
- •Known concurrent temporary secondary causes of AF;
- •Received a Class I or Class III antiarrhythmic agent (including sotalol) within 5 half-lives of randomization or amiodarone or dronedarone within 4 weeks;
- •Received treatment with other drugs known to prolong the QT interval within 5 half-lives.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: Placebo Tablet (Drug)
Dose 1
Experimental
K201
干预措施: K201 Tablet (Drug)
Dose 2
Experimental
K201
干预措施: K201 Tablet (Drug)
Dose 3
Experimental
K201
干预措施: K201 Tablet (Drug)
结局指标
主要结局
proportion of subjects in sinus rhythm
时间窗: Day 28
time to first documented recurrence of symptomatic or asymptomatic AF
时间窗: 28 days
number of AF beats
时间窗: 10 days
time to first documented recurrence of symptomatic AF
时间窗: 28 days
time in AF
时间窗: 10 days
safety assessments: vital signs, laboratory assays, ECG parameters, physical exams, frequency of adverse events
时间窗: 42 days
次要结局
未报告次要终点
研究者
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