Danhong Injection in the Treatment of Chronic Stable Angina

Tracking Information
First Submitted Date ICMJE	September 5, 2012
First Posted Date ICMJE	September 7, 2012
Last Update Posted Date	October 12, 2016
Study Start Date ICMJE	December 2012
Actual Primary Completion Date	October 2016 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: September 6, 2012)	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 [ Time Frame: 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.
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01681316 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: September 6, 2012)	Total score of symptoms questionnaire of TCM [ Time Frame: 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） [ Time Frame: 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.; The frequency of anginal attack every week [ Time Frame: 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).; Canadian Cardiovascular Society (CCS) grading of angina pectoris [ Time Frame: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90 ]; Consumption of Short-acting Nitrates [ Time Frame: Day -7( if exist), Day 0, Day 7, Day 14, Day 30, Day 60, Day 90 ]; Change in the electrocardiogram (EKG) [ Time Frame: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90 ]; Changes in the Serum Lipid, the high-sensitivity C-Reactive Protein(hs-CRP) and the Platelet Aggregation Rate [ Time Frame: Day 0, Day 14 ]; Incidence of new-onset major vascular events in 90 days [ Time Frame: Day 90 ]Major adverse vascular events include ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction and vascular-related death.; Overall mortality in 90 days [ Time Frame: Day 90 ]; Incidence of severe hemorrhages in 90 days [ Time Frame: 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.; Incidence of moderate hemorrhages in 90 days [ Time Frame: 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 [ Time Frame: 90 days ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE; (submitted: January 29, 2015)	The profiles of micro-RNA in 60 patients selected from certain centers [ Time Frame: Day 0, Day 14, Day 90 ]; The profiles of mRNA in 60 patients selected from certain centers [ Time Frame: Day 0, Day 14, Day 90 ]
Original Other Outcome Measures ICMJE; (submitted: September 6, 2012)	Changes in exercise tolerance tests (ETT)in 290 patients at day 14 [ Time Frame: Day 14 ]Changes in Exercise Tolerance Tests (ETT) at day 14 was defined as change in time to 0.1mv ST-segment depression and change in the Total Exercise Duration (TED) during Exercise Tolerance Testing (ETT) from baseline to day 14.; The profiles of micro-RNA in 60 patients selected from certain centers [ Time Frame: Day 0, Day 14, Day 90 ]; The profiles of mRNA in 60 patients selected from certain centers [ Time Frame: Day 0, Day 14, Day 90 ]
Descriptive Information
Brief Title ICMJE	Danhong Injection in the Treatment of Chronic Stable Angina
Official Title ICMJE	A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Danhong Injection in the Treatment of Chronic Stable Angina
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 Provided
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Chronic Stable Angina
Intervention ICMJE	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.
Study Arms	Experimental: 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. Interventions: Drug: Danhong injection Other: Standard medical care; Placebo Comparator: 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. Interventions: Other: Standard medical care Drug: Placebo
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: October 11, 2016)	920
Original Estimated Enrollment ICMJE; (submitted: September 6, 2012)	870
Actual Study Completion Date	October 2016
Actual Primary Completion Date	October 2016 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 70 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	China
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01681316
Other Study ID Numbers ICMJE	DH20120703
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Zhong Wang, China Academy of Chinese Medical Sciences
Study Sponsor ICMJE	China Academy of Chinese Medical Sciences
Collaborators ICMJE	China Food and Drug Administration
Investigators ICMJE	Principal Investigator: Zhong Wang, Professor Institute of Basic Research in Clinical Medicine，China Academy of Chinese Medical Sciences Principal Investigator: Yun-dai Chen, Professor Chinese PLA General Hospital(301 Hospital) Study Chair: Yong-yan Wang, Professor Institute of Basic Research in Clinical Medicine，China Academy of Chinese Medical Sciences Study Director: Xiao-xi Du, Professor China Food and Drug Administration
PRS Account	China Academy of Chinese Medical Sciences
Verification Date	October 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP