跳至主要内容
临床试验/NCT01590979
NCT01590979终止不适用

Randomized Double Blind Control Trial on Effects of Ranolazine on New Onset Atrial Fibrillation Rates in Post-Operative Cardiac Surgery Patients

Northwell Health1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2012年4月最近更新:
适应症
干预措施

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Ranolazine

Active Comparator

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

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Soad Bekheit

Director of Electrophysiology Lab

Northwell Health

研究点 (1)

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