Danhong Injection in the Treatment of Chronic Stable Angina
- Conditions
- Chronic Stable Angina
- Interventions
- Drug: Danhong injectionOther: Standard medical careDrug: Placebo
- Registration Number
- NCT01681316
- Lead Sponsor
- China Academy of Chinese Medical Sciences
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 920
- 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 ≥ 15. 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-5.
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Danhong injection 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. Danhong injection Standard medical care 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. Placebo Standard medical care 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. Placebo 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.
- Primary Outcome Measures
Name Time Method 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 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.
- Secondary Outcome Measures
Name Time Method The frequency of anginal attack every week Day-7 (if exist), Day 0, Day 7, Day 14, Day 30, Day 60, Day 90 The frequency of anginal attack was recorded by the patients with the use of the diary cards which will be collected from the run-in period (Day -7) to the end of follow-up (Day 90).
Total score of symptoms questionnaire of TCM Day 0, Day 7, Day 14, Day 30, Day 60, Day 90 The symptoms questionnaire of TCM consists of 6 symptoms that described in traditional Chinese medicine, including chest pain, chest distress, palpitation, dark-purple lip, dark-purple tongue and unsmooth pulse. Each symptom was assessed by the Visual Analogue Scale（VAS），where a higher score meant higher severity.
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 We defined clinical significant changes as a difference of 8 points or more on the physical-limitation scale, 25 or more on the angina-stability scale, 12 or more on the treatment-satisfaction scale, or 16 or more on the quality-of-life scale.
Canadian Cardiovascular Society (CCS) grading of angina pectoris Day 0, Day 7, Day 14, Day 30, Day 60, Day 90 Incidence of new-onset major vascular events in 90 days Day 90 Major adverse vascular events include ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction and vascular-related death.
Overall mortality in 90 days 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 severe hemorrhages in 90 days Day 90 The definition of "Severe hemorrhages" is in accordance with the GUSTO bleeding criteria, including fatal intracranial hemorrhage (ICH), symptomatic intracerebral hemorrhage (sICH) or which could result in substantial hemodynamic compromise requiring treatment.
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 The definition of "moderate hemorrhages" is in accordance with the GUSTO bleeding criteria, which requires blood transfusion but not results in hemodynamic compromise.
Documentation of adverse events (AEs) and serious AEs 90 days
Trial Locations
- Locations (31)
The First Affiliated Hospital of Henan University of T.C.M.
🇨🇳Zhengzhou, Henan, China
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
🇨🇳Beijing, Beijing, China
Chinese PLA General Hospital(301 Hospital)
🇨🇳Beijing, Beijing, China
Hubei Provincial Hospital of T.C.M.
🇨🇳Wuhan, Hubei, China
Xuan Wu Hospital Affiliated to Capital Medical University
🇨🇳Beijing, Beijing, China
The Third People's Hospital of Chongqing
🇨🇳Chongqing, Chongqing, China
The Second Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine
🇨🇳Ha'erbin, Heilongjiang, China
Dongfang Hospital
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Chongqing Traditional Chinese Medicine Hopital
🇨🇳Chongqing, Chongqing, China
People's Hospital of Zhengzhou
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine
🇨🇳Ha'erbin, Heilongjiang, China
Changsha Central Hospital
🇨🇳Changsha, Hunan, China
The First Hospital of Changsha
🇨🇳Changsha, Hunan, China
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Renmin Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
The Second Affiliated Hospital to Hunan University of Chinese Medicine
🇨🇳Changsha, Hunan, China
Jilin Province People's Hospital
🇨🇳Changchun, Jilin, China
The Affiliated Hospital to Changchun University of Chinese Medicine
🇨🇳Changchun, Jilin, China
Shanghai Tenth People's Hospital
🇨🇳Shanghai, Shanghai, China
Affiliated Zhongshan Hospital of Dalian University
🇨🇳Dalian, Liaoning, China
Shanghai Tongji Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai Municipal Hospital of Traditional Chinese Medicine
🇨🇳Shanghai, Shanghai, China
Shanxi Provincial People's Hospital
🇨🇳Xi'an, Shanxi, China
The First Affiliated Hospital to Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
Xi'an City Hospital of T.C.M.
🇨🇳Xi'an, Shanxi, China
Affiliated Hospital of Shanxi University of Chinese Medicine
🇨🇳Xianyang, Shanxi, China
Chengdu Sencond People's Hospital
🇨🇳Chengdu, Sichuan, China
Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
🇨🇳Tianjin, Tianjin, China
Shanxi Province Hosptial of T.C.M.
🇨🇳Xi'an, Shanxi, China
Xin Hua Hospital of Zhejiang Province
🇨🇳Hangzhou, Zhejiang, China