NCT00124891终止2 期
Study Evaluating Subjects With Non-sustained Ventricular Tachycardia
Wyeth is now a wholly owned subsidiary of Pfizer73 个研究点 分布在 10 个国家目标入组 500 人开始时间: 2005年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 500
- 试验地点
- 73
- 主要终点
- The total number of ventricular beats recorded by Holter monitoring during the 24 hr. on-therapy phase.
研究概览
简要总结
To determine whether the administration of test article will decrease the occurrence of ventricular arrhythmias in patients who have acute coronary syndrome (unstable angina, ST segment elevated myocardial infarction or myocardial infarction without ST elevation).
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
- Double
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
- •Male and female patients, 18 years of age or older, that have experienced an acute ischemic event within 24 hours prior to study entry.
- •Patients with a documented history of coronary artery disease or left ventricular dysfunction
- •Patients who have experienced an episode of non-sustained ventricular tachycardia within 24 hours of the index ischemic event
排除标准
- •Patients who have had percutaneous coronary intervention (PCI), thrombolytics, or open-heart surgery within 48 hours prior to study entry, or who require it during test article administration
- •Patients who have taken another antiarrhythmic medication (other than a beta blocker) within 5 half-lives of the start of test article
- •Patients who have a history of torsades de pointes, long QT syndrome, QTc > 0.50
结局指标
主要结局
The total number of ventricular beats recorded by Holter monitoring during the 24 hr. on-therapy phase.
次要结局
- The total number of NSVT beats, PVCs/couplets, NSVT episodes during the 24 hr. on-therapy phase and incidence of new-onset atrial fibrillation during the 24hr. on-therapy phase.
研究者
研究点 (73)
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