跳至主要内容
临床试验/NCT03037047
NCT03037047Unknown4 期

Efficacy and Safety of Salvianolate Injection in Elderly Patients With Unstable Angina Pectoris: a Parallel, Double Blind, Randomized, Controlled, Multi-center Trial.

Green Valley Group of China1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2016年5月11日最近更新:
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
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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Control group

Placebo Comparator

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

Experimental

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)

研究者

发起方
Green Valley Group of China
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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