NCT02158559Unknown4 期
A Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Trial of the Effect of Danhong Injection on Microcirculation in the Treatment of Patients With STEMI(ST- Elevation Myocardical Infarction) After the PTCA Surgery.
Beijing Bozhiyin T&S Co., Ltd.0 个研究点目标入组 180 人开始时间: 2014年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 180
- 主要终点
- After 7 days surgery used magnetic resonance assessed myocardial perfusion and myocardial function.
研究概览
简要总结
This study focused on the effect of Danhong injection on microcirculation in the treatment of patients with STEMI(ST-elevation myocardical infarction) after the PTCA surgery.
详细描述
Research Topic.
- A randomized, double-blind, placebo-controlled, multi-center clinical trial of the effect of Danhong Injection on microcirculation in the treatment of patients with STEMI(ST- elevation myocardical infarction) after the PTCA surgery.
Research Purpose.
- This study focused on the effect of Danhong injection on microcirculation in the treatment of patients with STEMI(ST-elevation myocardical infarction) after the PTCA surgery.
Research design.
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
- Double (Participant, Investigator)
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
- •Clinically definite or laboratory-supported diagnosis of STEMI ,with the indication of PTCA surgery.
- •18≤Age≤75;
- •Agreed to join in the study and signed the inform consent form.
排除标准
- •Cardiogenic shock , Killip III-IV degree , papillary muscle rupture , septal perforation , episodes of ventricular tachycardia and ventricular fibrillation after electrical cardioversion , temporary pacemaker implanted AVB III degree.
- •Past history of PCI and CABG
- •Acute or chronic infectious diseases(for example severe pneumonia);
- •Recent history of hemorrhagic stroke(within six months)
- •Combined with liver and kidney dysfunction;
- •History of valvular heart disease;
- •Congenital heart disease or Pulmonary hypertension;
- •All kinds of history of cardiomyopathy;
- •Bleeding and other thrombotic diseases;
- •Severe anemia , thrombocytopenia , Other diseases of the blood system;
- •Cancer , Autoimmune disease , All kinds of the patients who use the glucocorticoid and immunosuppressor;
- •Menstrual period women, pregnant women and lactating women, pregnancy test positive or recent family planning.
研究组 & 干预措施
Danhong Injection
Experimental
Danhong injection 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 7 days;
干预措施: Danhong Injection (Drug)
Normal Saline
Placebo Comparator
0.9% sodium chloride solution 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 7 days;
干预措施: Normal Saline (Drug)
结局指标
主要结局
After 7 days surgery used magnetic resonance assessed myocardial perfusion and myocardial function.
时间窗: 1 week
次要结局
未报告次要终点
研究者
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