Chronic Stable AnginaPhase 4NCT01681316
Danhong Injection in the Treatment of Chronic Stable Angina
A Phase 4 study testing Danhong injection and Standard medical care in people with Chronic Stable Angina, run by China Academy of Chinese Medical Sciences at 31 sites in China.
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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Stable Angina
- What is being tested?
- Danhong injection and Standard medical care
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 920 participants
- Where
- 31 sitesChina
- Study dates
- Dec 2012to Oct 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
China31 sites
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100053
Xuan Wu Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100053
Dongfang Hospital
Beijing, Beijing Municipality, 100078
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Chinese PLA General Hospital(301 Hospital)
Beijing, Beijing Municipality, 100853
Jilin Province People's Hospital
Changchun, Jilin, 130021
The Affiliated Hospital to Changchun University of Chinese Medicine
Changchun, Jilin, 130021
Changsha Central Hospital
Changsha, Hunan, 410004
The First Hospital of Changsha
Changsha, Hunan, 410005
The Second Affiliated Hospital to Hunan University of Chinese Medicine
Changsha, Hunan, 410005
Chengdu Sencond People's Hospital
Chengdu, Sichuan, 610017
Chongqing Traditional Chinese Medicine Hopital
Chongqing, Chongqing Municipality, 400011
The Third People's Hospital of Chongqing
Chongqing, Chongqing Municipality, 400014
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, 116001
Xin Hua Hospital of Zhejiang Province
Hangzhou, Zhejiang, 310005
The Second Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine
Harbin, Heilongjiang, 150009
The First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine
Harbin, Heilongjiang, 150040
Shanghai Tongji Hospital
Shanghai, Shanghai Municipality, 200065
Shanghai Municipal Hospital of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200071
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
The First Affiliated Hospital to Shanxi Medical University
Taiyuan, Shanxi, 030001
Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 300150
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430030
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Hubei Provincial Hospital of T.C.M.
Wuhan, Hubei, 430061
Xi'an City Hospital of T.C.M.
Xi’an, Shanxi, 710001
Shanxi Province Hosptial of T.C.M.
Xi’an, Shanxi, 710003
Shanxi Provincial People's Hospital
Xi’an, Shanxi, 710068
Affiliated Hospital of Shanxi University of Chinese Medicine
Xianyang, Shanxi, 712000
The First Affiliated Hospital of Henan University of T.C.M.
Zhengzhou, Henan, 450000
People's Hospital of Zhengzhou
Zhengzhou, Henan, 450053
About this study
Official title: A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Danhong Injection in the Treatment of Chronic Stable Angina
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
- Conditions
- Chronic Stable Angina
- Being tested
- Danhong injection, Standard medical care, Placebo
- Keywords
- Chronic Stable Angina, Randomized Controlled Trial, Traditional Chinese Medicine
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Danhong injectionDrug
A kind of injection made from two kind of Chinese herbs: salvia miltiorrhiza and safflower
Standard medical careOther
Standard medical care is in accordance with China Guideline for the diagnosis and treatment of Chronic Stable Angina (2007).
PlaceboDrug
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 group | Role | What they receive |
|---|---|---|
| Danhong injection | Experimental | 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. Receives: Drug: Danhong injection; Other: Standard medical care |
| Placebo | Placebo comparator | 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. Receives: Other: Standard medical care; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 30
Secondary outcomes (12)
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.
Measured: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
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.
Measured: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
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).
Measured: Day-7 (if exist), Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
Canadian Cardiovascular Society (CCS) grading of angina pectoris
Measured: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
Consumption of Short-acting Nitrates
Measured: Day -7( if exist), Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
Change in the electrocardiogram (EKG)
Measured: 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
Measured: Day 0, Day 14
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.
Measured: Day 90
Overall mortality in 90 days
Measured: Day 90
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.
Measured: Day 90
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.
Measured: Day 90
Documentation of adverse events (AEs) and serious AEs
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startDec 2012
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Stable AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 920 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- China Food and Drug Administration
- Responsible party
- Principal investigator, Zhong Wang, China Academy of Chinese Medical Sciences
- Investigators
- Zhong Wang, Professor, Principal investigator, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical SciencesYun-dai Chen, Professor, Principal investigator, Chinese PLA General Hospital(301 Hospital)Yong-yan Wang, Professor, Study chair, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical SciencesXiao-xi Du, Professor, Study director, China Food and Drug Administration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01681316
- Sponsor's protocol ID
- DH20120703
- Status last verified
- Oct 2016
- First submitted
- 5 Sep 2012
- Last updated
- 12 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Guan S, Yu YN, Li B, Gu H, Chen L, Wang N, Wang B, Liu X, Liu J, Wang Z. Discovery of Drug-Responsive Phenomic Alteration-Related Driver Genes in the Treatment of Coronary Heart Disease. Pharmgenomics Pers Med. 2023 Mar 15;16:201-217. doi: 10.2147/PGPM.S398522. eCollection 2023.
PubMed 36945217Liu 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.
PubMed 34471087Wang 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.
PubMed 26489511
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Danhong Injection in the Treatment of Chronic Stable Angina
- ClinicalTrials.gov ID
- NCT01681316
- Acronym / sponsor ID
- DH20120703
- Conditions
- Chronic Stable Angina
- Keywords
- Chronic Stable Angina, Randomized Controlled Trial, Traditional Chinese Medicine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 920 participants (actual)
- Lead sponsor
- China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- China Food and Drug Administration
- Study start
- Dec 2012
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 7 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Danhong injection | Experimental | Drug: Danhong injection, Other: Standard medical careBased 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 | Placebo comparator | Other: Standard medical care, Drug: PlaceboBased 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Danhong injectionA kind of injection made from two kind of Chinese herbs: salvia miltiorrhiza and safflower | Drug | Danhong injection |
| Standard medical careStandard medical care is in accordance with China Guideline for the diagnosis and treatment of Chronic Stable Angina (2007). | Other | Danhong injection, Placebo |
| Placebo0.9% 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. | Drug | Placebo |
Primary outcome
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.
12 secondary outcomes
Total score of symptoms questionnaire of TCM
Time frame: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
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
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
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
Overall mortality in 90 days
Time frame: Day 90
Incidence of severe hemorrhages in 90 days
Time frame: Day 90
Incidence of moderate hemorrhages in 90 days
Time frame: Day 90
Documentation of adverse events (AEs) and serious AEs
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2016.
- Derived from this study: PubMed 36945217Guan S, Yu YN, Li B, Gu H, Chen L, Wang N, Wang B, Liu X, Liu J, Wang Z. Discovery of Drug-Responsive Phenomic Alteration-Related Driver Genes in the Treatment of Coronary Heart Disease. Pharmgenomics Pers Med. 2023 Mar 15;16:201-217. doi: 10.2147/PGPM.S398522. eCollection 2023.
- Derived from this study: PubMed 34471087Liu 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.
- Derived from this study: PubMed 26489511Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhong Wang, Professor principal investigator
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Yun-dai Chen, Professor principal investigator
Chinese PLA General Hospital(301 Hospital)
Yong-yan Wang, Professor study chair
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Danhong injection and Standard medical care in people with Chronic Stable Angina, run by China Academy of Chinese Medical Sciences at 31 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01681316, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2016.