Randomized Double Blind Control Trial on Effects of Ranolazine on New Onset Atrial Fibrillation Rates in Post-Operative Cardiac Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Incidence of New Onset Atrial Fibrillation Rate in Post-Operative Cardiac Surgery Patients
研究概览
简要总结
The aim of this study is to evaluate the prophylactic effects of Ranolazine on new onset atrial fibrillation in post-operative coronary artery bypass graft and valve surgery patient population at Staten Island University hospital.
详细描述
Atrial fibrillation (AF) is a common complication of cardiac surgery. It has been shown that the onset of AF increases in post-operative cardiac surgery population. The rate of AF after coronary artery bypass graft (CABG) procedure range from 10-65% and from 37-50% after valve surgery. Rates of new onset AF are lower for CABG compared to valve procedures. The pathophysiology of post-operative AF is not well elucidated. It has been postulated that pre-operative factors such as age, past medical history, operative and post-operative remodeling of the coronary system and hemodynamic pressure changes may contribute to post-operative AF.
Ranolazine is currently approved as an antianginal drug. The antianginal properties of the drug are due to inhibition of the late inward sodium current. Through the same mechanism it has been demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias.
Therefore it is important to prevent or minimize the incidence of new onset post-operative AF in post-surgical population.
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
- Triple (Participant, Care Provider, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ranolazine
The antianginal properties of the drug are due to inhibition of the late inward sodium current, demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias.
干预措施: Ranolazine (Drug)
Placebo
Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals)
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of New Onset Atrial Fibrillation Rate in Post-Operative Cardiac Surgery Patients
时间窗: 3 weeks after surgery
次要结局
未报告次要终点
研究者
Soad Bekheit
Director of Electrophysiology Lab
Northwell Health
