Clinical trial NCT01681316: Danhong Injection in the Treatment of Chronic Stable Angina
Official title: A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Danhong Injection in the Treatment of Chronic Stable Angina
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Stable Angina
Keywords: Chronic Stable Angina
Randomized Controlled Trial
Traditional Chinese Medicine
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: China Food and Drug Administration
First posted: 2012-09-07
Enrollment: 920
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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
timeFrame: Day 30
Secondary outcomes:
measure: Total score of symptoms questionnaire of TCM
timeFrame: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
measure: 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）
timeFrame: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
measure: The frequency of anginal attack every week
timeFrame: Day-7 (if exist), Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
measure: Canadian Cardiovascular Society (CCS) grading of angina pectoris
timeFrame: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
measure: Consumption of Short-acting Nitrates
timeFrame: Day -7( if exist), Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
measure: Change in the electrocardiogram (EKG)
timeFrame: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
measure: Changes in the Serum Lipid, the high-sensitivity C-Reactive Protein(hs-CRP) and the Platelet Aggregation Rate
timeFrame: Day 0, Day 14
measure: Incidence of new-onset major vascular events in 90 days
timeFrame: Day 90
measure: Overall mortality in 90 days
timeFrame: Day 90
measure: Incidence of severe hemorrhages in 90 days
timeFrame: Day 90
measure: Incidence of moderate hemorrhages in 90 days
timeFrame: Day 90
measure: Documentation of adverse events (AEs) and serious AEs
timeFrame: 90 days
Other outcomes:
measure: The profiles of micro-RNA in 60 patients selected from certain centers
timeFrame: Day 0, Day 14, Day 90
measure: The profiles of mRNA in 60 patients selected from certain centers
timeFrame: Day 0, Day 14, Day 90
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Xuan Wu Hospital Affiliated to Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Dongfang Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital(301 Hospital)
state: Beijing
city: Chongqing
country: China
facility: Chongqing Traditional Chinese Medicine Hopital
state: Chongqing
city: Chongqing
country: China
facility: The Third People's Hospital of Chongqing
state: Chongqing
city: Ha'erbin
country: China
facility: The Second Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine
state: Heilongjiang
city: Ha'erbin
country: China
facility: The First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine
state: Heilongjiang
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Henan University of T.C.M.
state: Henan
city: Zhengzhou
country: China
facility: People's Hospital of Zhengzhou
state: Henan
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Hubei Provincial Hospital of T.C.M.
state: Hubei
city: Changsha
country: China
facility: Changsha Central Hospital
state: Hunan
city: Changsha
country: China
facility: The First Hospital of Changsha
state: Hunan
city: Changsha
country: China
facility: The Second Affiliated Hospital to Hunan University of Chinese Medicine
state: Hunan
city: Changchun
country: China
facility: Jilin Province People's Hospital
state: Jilin
city: Changchun
country: China
facility: The Affiliated Hospital to Changchun University of Chinese Medicine
state: Jilin
city: Dalian
country: China
facility: Affiliated Zhongshan Hospital of Dalian University
state: Liaoning
city: Shanghai
country: China
facility: Shanghai Tongji Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Municipal Hospital of Traditional Chinese Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
city: Taiyuan
country: China
facility: The First Affiliated Hospital to Shanxi Medical University
state: Shanxi
city: Xi'an
country: China
facility: Xi'an City Hospital of T.C.M.
state: Shanxi
city: Xi'an
country: China
facility: Shanxi Province Hosptial of T.C.M.
state: Shanxi
city: Xi'an
country: China
facility: Shanxi Provincial People's Hospital
state: Shanxi
city: Xianyang
country: China
facility: Affiliated Hospital of Shanxi University of Chinese Medicine
state: Shanxi
city: Chengdu
country: China
facility: Chengdu Sencond People's Hospital
state: Sichuan
city: Tianjin
country: China
facility: Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
state: Tianjin
city: Hangzhou
country: China
facility: Xin Hua Hospital of Zhejiang Province
state: Zhejiang
Study officials:
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
name: Zhong Wang, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese PLA General Hospital(301 Hospital)
name: Yun-dai Chen, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
name: Yong-yan Wang, Professor
role: STUDY_CHAIR
affiliation: China Food and Drug Administration
name: Xiao-xi Du, Professor
role: STUDY_DIRECTOR
References:
citation: Liu J, Li DD, Dong W, Liu YQ, Wu Y, Tang DX, Zhang FC, Qiu M, Hua Q, He JY, Li J, Du B, Du TH, Niu LL, Jiang XJ, Cui B, Chen JB, Wang YG, Wang HR, Yu Q, He J, Mao YL, Bin XF, Deng Y, Tian YD, Han QH, Liu DJ, Duan LQ, Zhao MJ, Zhang CY, Dai HY, Li ZH, Xiao Y, Hu YZ, Huang XY, Xing K, Jiang X, Liu CF, An J, Li FC, Tao T, Jiang JF, Yang Y, Dong YR, Zhang L, Fu G, Li Y, Huang SW, Dou LP, Sun LJ, Zhao YQ, Li J, Xia Y, Liu J, Liu F, He WJ, Li Y, Tan JC, Lin Y, Zhou YB, Yang JF, Ma GQ, Chen HJ, Liu HP, Liu ZW, Liu JX, Luo XJ, Bin XH, Yu YN, Dang HX, Li B, Teng F, Qiao WM, Zhu XL, Chen BW, Chen QG, Shen CT, Wang YY, Chen YD, Wang Z. Detection of an anti-angina therapeutic module in the effective population treated by a multi-target drug Danhong injection: a randomized trial. Signal Transduct Target Ther. 2021 Sep 1;6(1):329. doi: 10.1038/s41392-021-00741-x.
citation: Wang PQ, Li DD, Dong W, Liu J, Yu YN, Shen CT, Chen QG, Chen BW, Chen YD, Wang Z. Danhong injection in the treatment of chronic stable angina: study protocol for a randomized controlled trial. Trials. 2015 Oct 21;16:474. doi: 10.1186/s13063-015-0998-1.