A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Danhong Injection in the Treatment of Chronic Stable Angina
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 920
- 试验地点
- 31
- 主要终点
- The proportion of patients in each treatment group who had clinically significant change as defined by the angina-frequency score on the Seattle Angina Questionnaire at day 30
研究概览
简要总结
The purpose of this study is to evaluate the effect of Danhong Injection on the relief of angina with the use of the Seattle Angina Questionnaire among patients with stable angina patients
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male inpatients.
- •Age: 18 - 70 years.
- •Patients with clinical diagnosis of chronic stable angina and must meet one of the following conditions:1）Patients who have a history of myocardial infarction and ST-T changes;2）Stenosis of more than 50% in at least one major epicardial coronary artery shown by Coronary Angiograph or CT Angiography; 3）Patients with coronary heart disease were determined by radionuclide angiocardiography.
- •Clinical diagnosis of "Xueyu Zheng" (Blood Stasis Syndrome) as the scores of Chinese medicine symptoms scales of "Xueyu Zheng" in angina ≥
- •The Chinese medicine symptoms scales of "Xueyu Zheng" is defined as following (1)chest pain-10, (2)chest distress-10, (3) palpitation-5, (4)purple or dark lip-5, (5) purple or dark tongue-5, (6) unsmooth pulse-
- •Patients with moderate angina pectoris (The definition of "moderate angina pectoris " is in accordance with the Canadian Cardiovascular Society (CCS) grading of angina pectoris,which be classified to II or III.
- •Patient is willing to participate voluntarily and to sign a written patient informed consent.
排除标准
- •Woman with pregnancy, lactation or positive result of pregnancy test, or woman who is under menstrual period.
- •Woman who disagree with contraception during treatment period
- •Patients with severe complications that would make the condition more complicated assessed by the investigator, including liver or renal dysfunction, severe cardiopulmonary dysfunction, pulmonary hypertension, chronic obstructive pulmonary disease, a history of epilepsy or cerebral hemorrhage .
- •Patients who were angina-free during the run-in period without taking any drug.
- •Patients with myocardial infarction or Canadian Cardiovascular Society (CCS) grading of angina pectoris class IV within the preceding 3 months
- •Patients with chest pain caused by other disease (e.g., acute myocardial infarction，severe neurosis，menopausal syndrome，hyperthyroidism).
- •Patients with history of drug-induced bleeding or history of bleeding caused by warfarin.
- •Patients with history of hematopoietic system diseases.
- •Patients who had surgery within the past 4 weeks and have hemorrhagic tendency.
- •Patients who is participating in other trials or has been participated in other trials in recent 3 months.
- •Patients with history of allergy or suspected allergic to the drug.
- •Patients who were suspected addicted into alcohol or drug abuse in the past 2 years.
- •Patients with mental disorder.
- •Patients who were unable to participate in the study as judged by investigator.
- •Patients who were family members or relatives of the research center staffs.
研究组 & 干预措施
Danhong injection
Based on the standard medical care, 40ml of Danhong injection, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2 hours.
干预措施: Danhong injection (Drug)
Danhong injection
Based on the standard medical care, 40ml of Danhong injection, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2 hours.
干预措施: Standard medical care (Other)
Placebo
Based on the standard medical care, placebo was 40ml of 0.9% saline, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2 hours.
干预措施: Standard medical care (Other)
Placebo
Based on the standard medical care, placebo was 40ml of 0.9% saline, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2 hours.
干预措施: Placebo (Drug)
结局指标
主要结局
The proportion of patients in each treatment group who had clinically significant change as defined by the angina-frequency score on the Seattle Angina Questionnaire at day 30
时间窗: Day 30
Seattle Angina Questionnaire, a 19-item questionnaire that quantifies physical limitations due to angina, any recent change in the severity of angina, the frequency of angina, satisfaction with treatment, and quality of life. Scores range from 0 to 100; higher scores indicate better health status.With a score of 20 or more on the angina-frequency scale indicating that the patient was clinically significant change.
次要结局
- The frequency of anginal attack every week(Day-7 (if exist), Day 0, Day 7, Day 14, Day 30, Day 60, Day 90)
- Total score of symptoms questionnaire of TCM(Day 0, Day 7, Day 14, Day 30, Day 60, Day 90)
- The proportion of patients in each treatment group who had clinically significant changes in the other four Seattle Angina Questionnaire scales （The physical limitation, angina stability, treatment satisfaction, and quality of life）(Day 0, Day 7, Day 14, Day 30, Day 60, Day 90)
- Canadian Cardiovascular Society (CCS) grading of angina pectoris(Day 0, Day 7, Day 14, Day 30, Day 60, Day 90)
- Consumption of Short-acting Nitrates(Day -7( if exist), Day 0, Day 7, Day 14, Day 30, Day 60, Day 90)
- Change in the electrocardiogram (EKG)(Day 0, Day 7, Day 14, Day 30, Day 60, Day 90)
- Incidence of new-onset major vascular events in 90 days(Day 90)
- Overall mortality in 90 days(Day 90)
- Incidence of severe hemorrhages in 90 days(Day 90)
- Changes in the Serum Lipid, the high-sensitivity C-Reactive Protein(hs-CRP) and the Platelet Aggregation Rate(Day 0, Day 14)
- Incidence of moderate hemorrhages in 90 days(Day 90)
- Documentation of adverse events (AEs) and serious AEs(90 days)
研究者
Zhong Wang
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
China Academy of Chinese Medical Sciences