Danhong Injection in the Treatment of Chronic Stable Angina

Chronic Stable Angina Clinical Trial

Official title:

A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Danhong Injection in the Treatment of Chronic Stable Angina

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01681316
• Other study ID #: DH20120703
• Status: Completed
• Phase: Phase 4
• First received: September 5, 2012
• Last updated: October 11, 2016
• Start date: December 2012
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 920
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Chronic Stable Angina

Intervention

Drug:
• Danhong injection
A kind of injection made from two kind of Chinese herbs: salvia miltiorrhiza and safflower

Other:
• Standard medical care
Standard medical care is in accordance with China Guideline for the diagnosis and treatment of Chronic Stable Angina (2007).

Drug:
• Placebo
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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
China Academy of Chinese Medical Sciences	China Food and Drug Administration

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The profiles of micro-RNA in 60 patients selected from certain centers		Day 0, Day 14, Day 90	Yes
Other	The profiles of mRNA in 60 patients selected from certain centers		Day 0, Day 14, Day 90	Yes
Primary	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.	Day 30	No
Secondary	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.	Day 0, Day 7, Day 14, Day 30, Day 60, Day 90	No
Secondary	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.	Day 0, Day 7, Day 14, Day 30, Day 60, Day 90	No
Secondary	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).	Day-7 (if exist), Day 0, Day 7, Day 14, Day 30, Day 60, Day 90	No
Secondary	Canadian Cardiovascular Society (CCS) grading of angina pectoris		Day 0, Day 7, Day 14, Day 30, Day 60, Day 90	No
Secondary	Consumption of Short-acting Nitrates		Day -7( if exist), Day 0, Day 7, Day 14, Day 30, Day 60, Day 90	No
Secondary	Change in the electrocardiogram (EKG)		Day 0, Day 7, Day 14, Day 30, Day 60, Day 90	No
Secondary	Changes in the Serum Lipid, the high-sensitivity C-Reactive Protein(hs-CRP) and the Platelet Aggregation Rate		Day 0, Day 14	No
Secondary	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.	Day 90	Yes
Secondary	Overall mortality in 90 days		Day 90	Yes
Secondary	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.	Day 90	Yes
Secondary	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.	Day 90	Yes
Secondary	Documentation of adverse events (AEs) and serious AEs		90 days	Yes