Efficacy and Safety of Salvianolate Injection in Elderly Patients With Unstable Angina Pectoris: a Parallel, Double Blind, Randomized, Controlled, Multi-center Trial.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- symptom of angina pectoris
研究概览
简要总结
This parallel, double blind, randomized, controlled, multi-center study will evaluate the efficacy and safety of salvianolate injection in elderly patients with unstable angina pectoris.
详细描述
This parallel, double blind, randomized, controlled, multi-center study will evaluate the efficacy and safety of salvianolate injection in elderly patients with unstable angina pectoris. Patients will treated with or without salvianolate injection on the basis of conventional therapy for 14 days. The primary measures of effectiveness include the change from baseline to the end of treatment in the angina scores.(Angina score table :sum of 4 items), the variation of EKG (level of the S-T segment)., Additional measures of effectiveness include the change from baseline to the end of the treatment in the Seattle Angina Questionnaire(SAQ),EuroQol-5 Dimensions(EQ-5D) will be performed throughout the study. Patients who complete the double-blind portion of the study will be followed up 28 days. Effectiveness will be assessed at 7 days, 14 days and 28 days. Safety evaluations (incidence of adverse events,, physical examinations, laboratory tests) will be performed at at 7 days, 14 days and 28 days of the study.
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
- 60 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Control group
patients will be treated by 0.9% sodium chloride injection on the basis of conventional therapy for 14 days.
干预措施: 0.9% Sodium Chloride Injection (Drug)
Experimental group
patients will be treated by salvianolate injection on the basis of conventional therapy for 14 days.
干预措施: salvianolate injection (Drug)
结局指标
主要结局
symptom of angina pectoris
时间窗: up to 14 days
次要结局
- Seattle angina scale score(up to 28 days)
- EQ-5D health scale(up to 28 days)
- Incidence of cardiovascular and cerebrovascular events(up to 28 days)
- thrombolysis in myocardial infarction risk score(up to 28 days)
