NCT04220372尚未招募4 期
The Efficacy and Safety of Tongxinluo Capsule in Patients With Coronary Microvascular Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Changes of Coronary Flow Reserve
研究概览
简要总结
To investigate the efficacy and safety of Tongxinluo in patients with microvascular angina pectoris. Long-term follow-up of 1 to 5 years will be performed to evaluate the effect of Tongxinluo on long-term adverse cardiovascular events in patients with coronary microvascular disease.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Repeated chest pain attacks with typical exertional angina pectoris or resting angina pectoris attacks;
- •Coronary normal or stenosis < 20%;
- •Ischemic depression in ST segment during resting or exercise;
- •Blood flow reserve (CFR) of the anterior descending coronary artery < 2.0;
- •Subjects or their guardians agreed to participate in this study.
排除标准
- •Previous myocardial infarction or PCI or CABG treatment;
- •A history of heart failure or LVEF < 50%;
- •Severe arrhythmia;
- •Myocarditis, Pericardium Disease, Valvular Disease, or Cardiomyopathy;
- •A history of stroke within half a year;
- •Diabetes difficult to control;
- •Refractory hypertension or hypertension accompanied by left ventricular wall thickness > 12 mm;
- •Familial hypercholesterolemia;
- •Takayasu arteritis, Kawasaki disease or coronary artery malformation;
- •Pregnant or nursing, or having the intention to give birth within one year;
- •Hepatic or renal dysfunction;
- •Other diseases which may cause serious risks to patients;
- •Requiring warfarin anticoagulant therapy; Taking potassium channel opener, CCB, ACEI drugs or traditional Chinese medicines;
- •Allergic to contrast agents or blood products;
- •Patients who participated in clinical research of other drugs within 3 months before being selected.
研究组 & 干预措施
Tongxinluo Capsule
Experimental
干预措施: Tongxinluo (Drug)
Placebo Capsule
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Changes of Coronary Flow Reserve
时间窗: 1 year
次要结局
未报告次要终点
研究者
Pan-Pan Hao
MD
Qilu Hospital of Shandong University
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