NCT01887353终止2 期
A Randomized, Double-blind, Placebo Controlled Study, Designed to Investigate the Effect of Ranolazine on Left Ventricular Diastolic Function in Patients With Symptomatic AF and Preserved Ejection Function, After the Subject Has Undergone a Successful External Electrical Cardioversion
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
- 8
- 试验地点
- 1
- 主要终点
- Time to First Atrial Fibrillation (AF) Recurrence
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of ranolazine in the prevention of recurrent atrial fibrillation in post-cardioversion patients with heart failure and preserved ejection fraction.
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
- 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
- •Male or non-pregnant female > 18 years of age;
- •Documentation of heart failure and who are in NYHA class II or III;
- •Documented history of symptomatic AF < 6 months in duration at the time of presentation, currently in AF at the time of the external electrical cardioversion, and successfully restored to normal sinus rhythm;
- •Percutaneous coronary intervention (PCI) patients who can be placed on anticoagulation with warfarin post-cardioversion (and not on rivaroxaban or dabigatran);
- •Demonstration of preserved ejection fraction (EF) by echocardiography;
- •Echocardiographic evidence of impaired diastolic filling.
排除标准
- •Known history of permanent or long-standing AF (> 6 months);
- •Other acutely reversible causes of AF, including but not limited to: hyperthyroidism, pericarditis, myocarditis or pulmonary embolism;
- •Known history of cirrhosis;
- •NYHA Class IV;
- •Myocardial Infarction, unstable angina, or coronary artery bypass graft surgery within three months prior to screening;
- •Percutaneous coronary intervention (PCI) within 4 weeks prior to screening, if these patients need to be placed on rivaroxaban or dabigatran post-cardioversion;
- •Clinically significant valvular disease;
- •Clinically significant pulmonary disease;
- •Stroke within 3 months prior to screening;
- •Creatinine clearance < 30 mL/min as calculated by Cockcroft-Gault formula;
- •Use of anti-arrhythmic drugs (Class Ia or IIIc) within 3 months prior to screening;
- •Concurrent use of drugs considered strong inhibitors of CYP3A;
- •Concurrent use of drugs considered as CYP3A inducers;
- •Prior treatment with ranolazine.
研究组 & 干预措施
Ranolazine
Active Comparator
干预措施: Ranolazine (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Time to First Atrial Fibrillation (AF) Recurrence
时间窗: up to 6 months
There were too few participants for an assessment of time to first recurrence, therefore the numbers of participants with recurrence up to 6 months is reported instead
次要结局
未报告次要终点
研究者
研究点 (1)
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