NCT02681978已完成4 期
Heart Rate Reduction by IVabradine for Improvement of ENDothELial Function in Patients With Coronary Artery Disease: the RIVENDEL Study
Campus Bio-Medico University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2014年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Flow-mediated dilation of the brachial artery
研究概览
简要总结
This study evaluates the effect of ivabradine on endothelial function in patients with coronary artery disease (CAD) after complete revascularization with percutaneous coronary angioplasty (PCI). At least 30 days after PCI, patients will be randomized to receive ivabradine 5 mg twice daily or to continue with standard medical therapy.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •history of stable coronary disease
- •complete coronary revascularization with PCI at least 1 month prior to recruitment
- •sinus rhythm
- •absence of anginal symptoms
排除标准
- •resting heart rate <60 beats per minute
- •severe reduction of left ventricle ejection fraction (<40%)
- •coronary artery by-pass surgery
- •myocardial infarction, stroke or cerebral transient ischemic attack within the previous 6 months
- •implanted pacemaker, cardioverter, or defibrillator
- •sick sinus syndrome
- •sinoatrial block
- •congenital long QT
- •complete atrioventricular block
研究组 & 干预措施
Ivabradine group
Active Comparator
Ivabradine 5 mg twice daily + standard medical therapy
干预措施: Ivabradine (Drug)
Ivabradine group
Active Comparator
Ivabradine 5 mg twice daily + standard medical therapy
干预措施: Standard medical therapy (Drug)
Control group
Other
Standard medical therapy
干预措施: Standard medical therapy (Drug)
结局指标
主要结局
Flow-mediated dilation of the brachial artery
时间窗: 8 weeks
次要结局
- Number of patients with flow-mediated dilation of the brachial artery <7%(8 weeks)
- Endothelium-independent dilation of the brachial artery(8 weeks)
- Correlation between heart rate and flow-mediated dilation of the brachial artery(8 weeks)
研究者
Germano Di Sciascio
Prof. Germano Di Sciascio
Campus Bio-Medico University
研究点 (1)
Loading locations...
相似试验
已完成
3 期
The BEAUTIFUL Study: Effects of Ivabradine in Patients With Stable Coronary Artery Disease and Left Ventricular Systolic DysfunctionCoronary DiseaseVentricular Dysfunction, LeftNCT00143507Institut de Recherches Internationales Servier10,917
撤回
4 期
Ivabradine and Post-revascularisation Microcirculatory DysfunctionCoronary Artery DiseaseAnginaNCT02507050Liverpool Heart and Chest Hospital NHS Foundation Trust
进行中（未招募）
不适用
Ivabradine IN IMPROVING THE EFFECTIVENESS OF THE ENDOTHELIAL FUNCTION IN PATIENTS WITH CAD undergoing coronary angioplastyEUCTR2012-005359-18-ITIVERSITA' CAMPUS BIOMEDICO
已完成
2 期
Efficacy of Oral Ivabradine in Patients Presenting With NSTEMINSTEMINCT04285736Cairo University100
已完成
3 期
Effects of Ivabradine on Cardiovascular Events in Patients With Moderate to Severe Chronic Heart Failure and Left Ventricular Systolic Dysfunction. A Three-year International Multicentre StudyChronic Heart FailureNCT02441218Institut de Recherches Internationales Servier6,505