Safety of Amiodarone and Ranolazine Together in Patients With Stable Angina
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- ventricular arrhythmia
研究概览
简要总结
Ranolazine is an effective and remarkably safe agent for the treatment of patients with chronic stable angina, but its inhibition of voltage gated potassium channels and electrocardiogram (EKG) corrected QT (QTc) prolongation properties have lead many to question its safety when combined with antiarrhythmic drugs. The investigators have proposed a study to determine the safety of ranolazine in patients with chronic stable angina who also take amiodarone. And are conducting a prospective single-center randomized single-blinded placebo controlled trial to run out of our large cardiology practice setting at Cardiovascular Consultants of Nevada. The hypothesis is that there will be no difference in the ventricular arrhythmia burden. The primary outcome will be the measurement of ventricular arrhythmia episodes on serial holter monitor and other serially acquired recordings (such as electrocardiogram, pacemaker or implantable defibrillator (ICD) data, and stress test data) over a three month trial period.
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
- Single (Participant)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ischemic cardiac disease
- •chronic anginal symptoms
- •on amiodarone therapy for other cardiac conditions
排除标准
- •non-English speaking
- •unstable angina
- •baseline electrocardiogram (EKG) corrected QT (QTc)>490ms
- •severe thyroid dysfunction
- •heart block without a pacer system
- •liver disease
研究组 & 干预措施
sugar pill
one pill twice daily, uptitrated to two pills twice daily to mirror ranolazine prescription strategy
干预措施: placebo (Drug)
Ranolazine
500 mg twice daily, titrated to 1000 mg twice daily if needed for relief of anginal symptoms
干预措施: ranolazine (Drug)
结局指标
主要结局
ventricular arrhythmia
时间窗: 3 months
primary outcome is the burden of ventricular arrhythmias measured on serial holter monitor recordings, stress test recordings, pacemaker or implantable defibrillator (ICD) recordings if available, at baseline and serially to trial completion.
次要结局
- Electrocardiogram (EKG) corrected QT (QTc) interval measurement(over the 3 month trial)
- liver function assay(3 months)
- atrial arrhythmia burden(3 months)
- syncope hospitalization(3 months)
- hospitalization(3 months)