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Danhong Injection in the Treatment of Chronic Stable Angina

Primary Purpose

Chronic Stable Angina

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Danhong injection
Standard medical care
Placebo
Sponsored by
China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Stable Angina focused on measuring Chronic Stable Angina, Randomized Controlled Trial, Traditional Chinese Medicine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Guang'anmen Hospital, China Academy of Chinese Medical Sciences
  • Xuan Wu Hospital Affiliated to Capital Medical University
  • Dongfang Hospital
  • Peking University Third Hospital
  • Chinese PLA General Hospital(301 Hospital)
  • Chongqing Traditional Chinese Medicine Hopital
  • The Third People's Hospital of Chongqing
  • The Second Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine
  • The First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine
  • The First Affiliated Hospital of Henan University of T.C.M.
  • People's Hospital of Zhengzhou
  • Zhongnan Hospital of Wuhan University
  • Renmin Hospital of Wuhan University
  • Hubei Provincial Hospital of T.C.M.
  • Changsha Central Hospital
  • The First Hospital of Changsha
  • The Second Affiliated Hospital to Hunan University of Chinese Medicine
  • Jilin Province People's Hospital
  • The Affiliated Hospital to Changchun University of Chinese Medicine
  • Affiliated Zhongshan Hospital of Dalian University
  • Shanghai Tongji Hospital
  • Shanghai Municipal Hospital of Traditional Chinese Medicine
  • Shanghai Tenth People's Hospital
  • The First Affiliated Hospital to Shanxi Medical University
  • Xi'an City Hospital of T.C.M.
  • Shanxi Province Hosptial of T.C.M.
  • Shanxi Provincial People's Hospital
  • Affiliated Hospital of Shanxi University of Chinese Medicine
  • Chengdu Sencond People's Hospital
  • Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
  • Xin Hua Hospital of Zhejiang Province

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Danhong injection

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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

Total score of symptoms questionnaire of TCM
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）
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.
The frequency of anginal attack every week
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).
Canadian Cardiovascular Society (CCS) grading of angina pectoris
Consumption of Short-acting Nitrates
Change in the electrocardiogram (EKG)
Changes in the Serum Lipid, the high-sensitivity C-Reactive Protein(hs-CRP) and the Platelet Aggregation Rate
Incidence of new-onset major vascular events in 90 days
Major adverse vascular events include ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction and vascular-related death.
Overall mortality in 90 days
Incidence of severe hemorrhages in 90 days
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.
Incidence of moderate hemorrhages in 90 days
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

Full Information

First Posted
September 5, 2012
Last Updated
October 11, 2016
Sponsor
China Academy of Chinese Medical Sciences
Collaborators
China Food and Drug Administration
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1. Study Identification

Unique Protocol Identification Number
NCT01681316
Brief Title
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

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Academy of Chinese Medical Sciences
Collaborators
China Food and Drug Administration

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stable Angina
Keywords
Chronic Stable Angina, Randomized Controlled Trial, Traditional Chinese Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
920 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Danhong injection
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Danhong injection
Intervention Description
A kind of injection made from two kind of Chinese herbs: salvia miltiorrhiza and safflower
Intervention Type
Other
Intervention Name(s)
Standard medical care
Intervention Description
Standard medical care is in accordance with China Guideline for the diagnosis and treatment of Chronic Stable Angina (2007).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
0.9% saline added into 250ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Day 30
Secondary Outcome Measure Information:
Title
Total score of symptoms questionnaire of TCM
Description
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.
Time Frame
Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
Title
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）
Description
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.
Time Frame
Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
Title
The frequency of anginal attack every week
Description
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).
Time Frame
Day-7 (if exist), Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
Title
Canadian Cardiovascular Society (CCS) grading of angina pectoris
Time Frame
Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
Title
Consumption of Short-acting Nitrates
Time Frame
Day -7( if exist), Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
Title
Change in the electrocardiogram (EKG)
Time Frame
Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
Title
Changes in the Serum Lipid, the high-sensitivity C-Reactive Protein(hs-CRP) and the Platelet Aggregation Rate
Time Frame
Day 0, Day 14
Title
Incidence of new-onset major vascular events in 90 days
Description
Major adverse vascular events include ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction and vascular-related death.
Time Frame
Day 90
Title
Overall mortality in 90 days
Time Frame
Day 90
Title
Incidence of severe hemorrhages in 90 days
Description
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.
Time Frame
Day 90
Title
Incidence of moderate hemorrhages in 90 days
Description
The definition of "moderate hemorrhages" is in accordance with the GUSTO bleeding criteria, which requires blood transfusion but not results in hemodynamic compromise.
Time Frame
Day 90
Title
Documentation of adverse events (AEs) and serious AEs
Time Frame
90 days
Other Pre-specified Outcome Measures:
Title
The profiles of micro-RNA in 60 patients selected from certain centers
Time Frame
Day 0, Day 14, Day 90
Title
The profiles of mRNA in 60 patients selected from certain centers
Time Frame
Day 0, Day 14, Day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhong Wang, Professor
Organizational Affiliation
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yun-dai Chen, Professor
Organizational Affiliation
Chinese PLA General Hospital(301 Hospital)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yong-yan Wang, Professor
Organizational Affiliation
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Xiao-xi Du, Professor
Organizational Affiliation
China Food and Drug Administration
Official's Role
Study Director
Facility Information:
Facility Name
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Facility Name
Xuan Wu Hospital Affiliated to Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Facility Name
Dongfang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100078
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Chinese PLA General Hospital(301 Hospital)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Chongqing Traditional Chinese Medicine Hopital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400011
Country
China
Facility Name
The Third People's Hospital of Chongqing
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400014
Country
China
Facility Name
The Second Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine
City
Ha'erbin
State/Province
Heilongjiang
ZIP/Postal Code
150009
Country
China
Facility Name
The First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine
City
Ha'erbin
State/Province
Heilongjiang
ZIP/Postal Code
150040
Country
China
Facility Name
The First Affiliated Hospital of Henan University of T.C.M.
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Facility Name
People's Hospital of Zhengzhou
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450053
Country
China
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Facility Name
Hubei Provincial Hospital of T.C.M.
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430061
Country
China
Facility Name
Changsha Central Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410004
Country
China
Facility Name
The First Hospital of Changsha
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410005
Country
China
Facility Name
The Second Affiliated Hospital to Hunan University of Chinese Medicine
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410005
Country
China
Facility Name
Jilin Province People's Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
The Affiliated Hospital to Changchun University of Chinese Medicine
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Affiliated Zhongshan Hospital of Dalian University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116001
Country
China
Facility Name
Shanghai Tongji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200065
Country
China
Facility Name
Shanghai Municipal Hospital of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200071
Country
China
Facility Name
Shanghai Tenth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China
Facility Name
The First Affiliated Hospital to Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
Facility Name
Xi'an City Hospital of T.C.M.
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710001
Country
China
Facility Name
Shanxi Province Hosptial of T.C.M.
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710003
Country
China
Facility Name
Shanxi Provincial People's Hospital
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710068
Country
China
Facility Name
Affiliated Hospital of Shanxi University of Chinese Medicine
City
Xianyang
State/Province
Shanxi
ZIP/Postal Code
712000
Country
China
Facility Name
Chengdu Sencond People's Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610017
Country
China
Facility Name
Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300150
Country
China
Facility Name
Xin Hua Hospital of Zhejiang Province
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310005
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
34471087
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.
Results Reference
derived
PubMed Identifier
26489511
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.
Results Reference
derived

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Danhong Injection in the Treatment of Chronic Stable Angina

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