Coronary Heart DiseasePhase 4HEARTPOWERNCT07110415
Efficacy and Safety Trials of Yangxinshi Tablets in the Treatment of Patients With Coronary Heart Disease Complicated by Cardiac Dysfunction
A Phase 4 study testing Yangxinshi tablet in people with Coronary Heart Disease and Cardiac Dysfunction, run by SPH Qingdao Growful Pharmacetical Co.,Ltd at 96 sites in China.
Trial summary
A randomized controlled trial was conducted to evaluate the efficacy and safety of Yangxinshi tablets in improving the condition of patients with coronary heart disease complicated by cardiac dysfunction. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Coronary Heart Disease, Cardiac Dysfunction
- What is being tested?
- Yangxinshi tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,708 participants
- Where
- 96 sitesChina
- Study dates
- 6 Nov 2025to 31 Dec 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For inpatients diagnosed with coronary heart disease (including acute coronary syndrome and chronic coronary syndrome), it is up to the doctor to decide whether to undergo revascularization and what kind of revascularization to use.
- Patients aged between 40 and 80 years (inclusive), regardless of sex;
- Patients with NYHA cardiac function classes II-IV;
- Patients with NT-proBNP > 125 pg/mL (or BNP>35 pg/mL);
- The syndrome differentiation in traditional Chinese medicine conforms to chest obstruction (qi deficiency and blood stasis syndrome)
- Patients who voluntarily participated and signed an informed consent form.
Who cannot join
- Patients with STEMI within 3 days;
- Patients at extremely high risk of NSTEMI (hemodynamic instability, cardiogenic shock, new-onset heart failure or aggravated heart failure, severe ventricular arrhythmia)
- Patients with acute myocardial infarction complicated with cardiogenic shock, mechanical complications, respiratory failure and other multiple organ failure;
- Patients with severe liver dysfunction (transaminase levels more than three times the upper limit of normal), renal insufficiency (eGFR < 30mL/min/1.73m2), acute infectious diseases, and mental disorders;以上翻译结果来自有道神经网络翻译(YNMT)· 通用场景
- Patients with drug-resistant hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg);
- Pregnant or lactating women, or those planning pregnancy during the study period;
Show all 12Show fewer
- Patients who cannot tolerate 3 months of dual antiplatelet therapy;
- Patients with allergic reactions or abnormal drug reactions to the study drug or any of its excipients;
- Patients who have regularly taken Yangxinshi tablets and similar traditional Chinese medicine, Chinese patent medicine or traditional Chinese medicine decoction with the same curative effectin the past month;
- Patients who have participated in other clinical drug trials within the last three months;
- Patients with malignant tumors and other pathological conditions with an expected survival of less than 3 years;
- Patients whom the investigator deems unsuitable for participating in the clinical trial.
Trial locations and contacts
96 sites in 1 country. Contact the study team or a site near you to ask about taking part.
96 sites in 1 country
China96 sites, 96 recruiting
- Not yet recruiting
Baoding No.1 Central Hospital
Baoding, Hebei
Wang hui qin
- Not yet recruiting
Beijing Hospital of Traditional Chinese Medicine
Beijing, Beijing Municipality
Shang ju ju
- Not yet recruiting
Dongfang Hospital,Beijing University of Chinese Medicine
Beijing, Beijing Municipality
Zhao hai bin
- Not yet recruiting
Guang'anmen Hospital,China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality
Zhang zhen peng
- Not yet recruiting
Jingjiang People's Hospital
Cangzhou, Hebei
Chen yang
- Not yet recruiting
Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Changchun, Jilin
Meng xiao ping
- Not yet recruiting
Jilin Provincial People's Hospital
Changchun, Jilin
Zhang xue lian
- Not yet recruiting
The First Bethune Hospital of Jilin University
Changchun, Jilin
Tong qian
- Not yet recruiting
The Second Norman Bethune Hospital of Jilin University
Changchun, Jilin
Liu bin
- Not yet recruiting
Hunan Provincial TCM Hospital
Changsha, Hunan
Xiong xiang hui
- Not yet recruiting
Chengdu Wenjiang District People's Hospital
Chengdu, Sichuan
Hou guo qing
- Not yet recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan
Tian wen jie
- Not yet recruiting
Chifeng Municipal Hospital
Chifeng, Neimenggu
Liu zhi hui
- Not yet recruiting
Army Specialty Medical Center
Chongqing, Chongqing Municipality
Zeng chun yu
- Not yet recruiting
Chongqing Emergency Medical Center
Chongqing, Chongqing Municipality
Xiao jun
- Not yet recruiting
Chongqing General Hospital
Chongqing, Chongqing Municipality
Ran bo li
- Not yet recruiting
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality
Zhang jian ming
- Not yet recruiting
The Southwest Hospital of Amu
Chongqing, Chongqing Municipality
Zhang zhi hui
- Not yet recruiting
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning
- Not yet recruiting
Dandong Central Hospital
Dandong, Liaoning
Jiang da ming
- Not yet recruiting
Daqing Oilfield General Hospital
Daqing, Heilongjiang
Fan zhi qing
- Not yet recruiting
Fushun Central Hospital
Fushun, Liaoning
Song zhan chun
- Not yet recruiting
Fuxin Central Hospital
Fuxin, Liaoning
Ying hai rong
- Not yet recruiting
Guang'an People's Hospital
Guang’an, Sichuan
Gou cheng
- Not yet recruiting
The affiliated traditional Chinese medicine hospital of Guangzhou Medical University
Guangzhou, Guangdong
Chen quan fu
- Not yet recruiting
The first affiliated hospital, Sun Yat-sen University
Guangzhou, Guangdong
Liao xin xue
- Not yet recruiting
The First Affiliated Hospital of Guilin Medical University
Guilin, Guangxi
Li quan zhong
- Not yet recruiting
The First Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou
Li wei
- Not yet recruiting
The First Affiliated Hospital of Harbin Medical University
Haerbin, Heilongjiang
Li yue
- Not yet recruiting
The Second Affiliated Hospital of Harbin Medical University
Haerbin, Heilongjiang
Hou jing bo
- Not yet recruiting
Handan Central Hospital
Handan, Hebei
Tian hong sen
- Not yet recruiting
Affiliated Hangzhou First People's Hospital,School of Medicine,Westlake University
Hangzhou, Zhejiang
Xu yi zhou
- Not yet recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Guo xiao gang
Zhang yun
- Not yet recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
Wang li hong
- Not yet recruiting
The People's Hospital of Bozhou
Haozhou, Anhui
Jiang rong yan
- Not yet recruiting
HeGang People's Hospital
Hegang, Heilongjiang
Chen feng jiao
- Not yet recruiting
Xuyi People's Hospital
Huai'an, Jiangsu
Bai song
- Not yet recruiting
Huzhou Central Hospital
Huzhou, Zhejiang
Lu kong jie
- Not yet recruiting
The People's Hospital of Jianyang City
Jiancheng, Sichuan
Luo zhi
- Not yet recruiting
The First Hospital of Jiaxing
Jiaxing, Zhejiang
Tang guan min
- Not yet recruiting
The Second Hospital of Jiaxing
Jiaxing, Zhejiang
Xu jian jiang
- Not yet recruiting
Jilin People's Hospital
Jilin City, Jilin
Zhang jin zi
- Not yet recruiting
Qilu Hospital of Shandong University
Jinan, Shandong
Yang jian min
- Not yet recruiting
Shandong University of Traditional Chinese Medicine Affiliated Hospital
Jinan, Shandong
Zhang yun
- Not yet recruiting
The 960th Hospital of the PLA Joint Logistics Support Force
Jinan, Shandong
Jin qun
- Not yet recruiting
The Fourth People's Hospital of Jinan
Jinan, Shandong
Wang tao
- Not yet recruiting
Yunnan Provincial Hospital of Traditional Chinese Medicine
Kunming, Yunnan
Luo shi hua
- Not yet recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu
Zhang zheng
- Not yet recruiting
The Second People's Hospital of Liaocheng
Liaocheng, Shandong
Zhang yun
- Not yet recruiting
Liuzhou People's Hospital
Liuzhou, Guangxi
Liu yan li
- Not yet recruiting
Mudanjiang Cardiovascular Disease Hospital
Mudanjiang, Heilongjiang
Liu kai
- Not yet recruiting
Nanjing Lishui People's Hospital
Nanjing, Jiangsu
Chen li juan
- Not yet recruiting
Zhongda Hospital Southeast University
Nanjing, Jiangsu
Li yong jun
- Not yet recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
Wu xiang hong
- Not yet recruiting
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi
Ji qing wei
- Not yet recruiting
Beilun Branch of the First Affiliated Hospital of Zhejiang University School of Medicine
Ningbo, Zhejiang
Wu qi
- Not yet recruiting
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang
Chen zhi kui
- Not yet recruiting
The Affiliated People'sHospital of Ningbo University
Ningbo, Zhejiang
Bao ying chun
- Not yet recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
Lian zhe xun
- Not yet recruiting
Fudan University Minhang Hospital
Shanghai, Shanghai Municipality
Hu wei
- Not yet recruiting
Ruijin Hospital Luban Branch, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Jin wei
Hua sha
- Not yet recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Jin wei
Chen yan jia
- Not yet recruiting
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality
Chen wen liang
Liu ban
- Not yet recruiting
Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Hou lei
- Not yet recruiting
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Zhang li
Xu xiao lei
- Not yet recruiting
The Second Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong
Chen you ren
- Not yet recruiting
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Shaoxing, Zhejiang
Fu guo sheng
Wang min
- Recruiting
General Hospital of Northern Theater Command
Shenyang, Liaoning, 110016
Han ya ling
- Not yet recruiting
The First Hospital of China Medical University
Shenyang, Liaoning
Sun ying xian
- Not yet recruiting
The Fourth Affiliated Hospital of China Medical University
Shenyang, Liaoning
Jin yuan zhe
- Not yet recruiting
The Eighth Affiliated Hospital,Sun Yat-sen University
Shenzhen, Shenzhen
Huang hui
- Not yet recruiting
Hebei General Hospital
Shijiazhuang, Hebei
Dang yi
- Not yet recruiting
Jiangsu Provincial People's Hospital Suqian Branch
Suqian, Jiangsu
Zhang zhi yong
- Not yet recruiting
Taizhou Fourth People's Hospital
Taizhou, Jiangsu
Chen a di
- Not yet recruiting
Taizhou Central Hospital
Taizhou, Zhejiang
Cai hai peng
- Not yet recruiting
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang
Jiang jian jun
- Not yet recruiting
Tengzhou Central People's Hospital
Tengzhou, Shandong
Yan jing peng
- Not yet recruiting
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality
Liu tong
- Not yet recruiting
Tianjin Chest Hospital
Tianjin, Tianjin Municipality
Cong hong liang
- Not yet recruiting
Tianjin Fifth Center Hospital
Tianjin, Tianjin Municipality
Wang kuan
- Not yet recruiting
Tianjin Hospital of Integrated Traditional Chinese and Western Medicine
Tianjin, Tianjin Municipality
Li yong jian
- Not yet recruiting
Affiliated Hospital of Shandong Second Medical University
Weifang, Shandong
Duan lu chang
- Not yet recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi
Deng jie
- Not yet recruiting
Xi'an Gaoling District Hospital
Xi’an, Shanxi
Wang yan
- Not yet recruiting
Xingtai People's Hospital
Xingtai, Hebei
Zhang you liang
- Not yet recruiting
Xuzhou No.1 People's Hospital
Xuzhou, Jiangsu
Zhao yue wu
- Not yet recruiting
PLA Joint Logistics Support Force No.970 Hospital
Yantai, Shandong
Wang hai tao
- Not yet recruiting
Yantai Affiliated Hospital of Binzhou Medical University
Yantai, Shandong
Cui ai dong
- Not yet recruiting
Yantai Yuhuangding Hospital
Yantai
Ren fa xin
- Not yet recruiting
General Hospital of Ningxia Medical University
Yinchuan, Ningxia
Qiu yu ming
- Not yet recruiting
Yiyang Central Hospital
Yiyang, Hunan
He hui
- Not yet recruiting
The First Affiliated Hospital of Hebei North University
Zhangjiakou, Hebei
Li fang jiang
- Not yet recruiting
The 7th People's Hospital of Zhengzhou
Zhengzhou, Henan
Yuan li xia
- Not yet recruiting
The Third People's Hospital of Zhengzhou
Zhengzhou, Henan
Bai dong yang
- Not yet recruiting
The Fifth Affiliated Hospital,Sun Yat-sen University
Zhuhai, Guangdong
Jin li zi
- Not yet recruiting
The First Affiliated Hospital of Zunyi Medical University"
Zunyi, Guizhou
Shi bei
About this study
Official title: A Randomized Controlled Trial of the Efficacy and Safety of Yangxinshi Tablets in the Treatment of Patients With Coronary Heart Disease Complicated by Cardiac Dysfunction
A randomized controlled trial was conducted to evaluate the efficacy and safety of Yangxinshi tablets in improving the condition of patients with coronary heart disease complicated by cardiac dysfunction.
Read the detailed description
The purpose of this study was to investigate whether the addition of Yangxinshi tablets to conventional treatment can reduce the composite endpoint time, increase exercise tolerance, and improve quality of life and mental health in patients with coronary heart disease complicated by cardiac dysfunction. A total of 2708 eligible patients were randomly divided into two groups. In addition to conventional treatment, the trial group was given Yangxinshi tablets (3 tablets/time, 3 times/day), while the control group was a blank control. The treatment cycle continued until the expected number of endpoint events was reached or the study ended, whichever occurred first. The primary endpoint was the composite endpoint of ischemic events or heart failure-related clinical events (including all-cause death, ischemia-driven revascularization, stroke, myocardial infarction (MI), and readmission due to aggravated ACS or heart failure) during the study period.
- Conditions
- Coronary Heart Disease, Cardiac Dysfunction
- Being tested
- Yangxinshi tablet, Blank control
- Keywords
- Yangxinshi, Coronary heart disease, Cardiac dysfunction
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yangxinshi tabletDrug
Also called Yangxinshi
Basic treatment: All patients received a conventional treatment regimen, including outcome-improving drugs (aspirin, P2Y12 receptor inhibitor、β-blockers, statins, ARNI /ACEI/ARB, SGLT2i, and MRA) and symptom-relieving drugs (nitrates, calcium antagonists, and loop diuretic).
Trial drug: Yangxinshi tablets, 3 tablets/3 times a day, taken orally
Blank controlDrug
Basic treatment: All patients received a conventional treatment regimen, including outcome-improving drugs (aspirin, P2Y12 receptor inhibitor、β-blockers, statins, ARNI /ACEI/ARB, SGLT2i, and MRA) and symptom-relieving drugs (nitrates, calcium antagonists, and loop diuretic).
Trial drug: Blank control
| Study group | Role | What they receive |
|---|---|---|
| Trial group | Experimental | Basic treatment and Trial drug Receives: Drug: Yangxinshi tablet |
| Control group | Sham comparator | Basic treatment Receives: Drug: Blank control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The composite endpoint was ischemic events or heart failure-related clinical events
All-cause death, ischemia-driven revascularization, stroke, MI, and readmission due to aggravated ACS or heart failure
Measured: Through study completion, an average of 3 years
Secondary outcomes (21)
Ischemic composite endpoint events
Cardiovascular and cerebrovascular death, MI, ischemia-driven revascularization, stroke, and readmission due to ACS
Measured: Through study completion, an average of 3 years
Heart failure-related clinical events
Readmission due to aggravated heart failure or all-cause death
Measured: Through study completion, an average of 3 years
Cardiovascular and cerebrovascular deaths
Occurrence of cardiovascular and cerebrovascular deaths
Measured: Through study completion, an average of 3 years
All-cause death
Occurrence of all-cause death
Measured: Through study completion, an average of 3 years
Readmission due to ACS
Readmission due to ACS
Measured: Through study completion, an average of 3 years
Readmission due to aggravated heart failure
Readmission due to aggravated heart failure
Measured: Through study completion, an average of 3 years
The cumulative incidence of readmission due to aggravated ACS or heart failure
The joint gamma frailty model was adopted for analysis
Measured: Through study completion, an average of 3 years
Win ratio
The main efficacy indicators were analyzed by using the win ratio method
Measured: Through study completion, an average of 3 years
6MWD
Change in 6-minute walking distance
Measured: From baseline at 48 weeks
NT-proBNP or BNP
Measurement of NT-proBNP or BNP, calculation of the proportion of patients achieving NT-proBNP <125 pg/mL (or BNP <35 pg/mL), and the degree of reduction
Measured: From baseline at 48 weeks
Patient Health Questionnaire - 9(PHQ-9) depression scale
The Patient Health Questionnaire - 9(PHQ-9)depression scale comprises nine questions. In each assessment area, scores range from 0 to 3 based on the increasing frequency of difficult: 0 indicates "not at all," 1 indicates "sometimes," 2 indicates "more than half the time," and 3 indicates "almost every day." The total score ranges from 0 to 27,higher scores mean a worse outcome.
Measured: After 24 and 48 weeks of treatment
Generalized Anxiety Disorder 7 - item Scale(GAD-7) anxiety scale
The Generalized Anxiety Disorder 7 - item Scale(GAD-7) anxiety scale comprises seven questions. In each assessment area, scores range from 0 to 3 based on the increasing frequency of difficult: 0 indicates "not at all," 1 indicates "sometimes," 2 indicates "more than half the time," and 3 indicates "almost every day." The total score ranges from 0 to 21,higher scores mean a worse outcome.
Measured: After 24 and 48 weeks of treatment
NYHA
Changes in New York Heart Association (NYHA) functional classification
Measured: After 24 and 48 weeks of treatment
SAQ
Changes in Seattle Angina Questionnaire (SAQ) scores.The SAQ scale is divided into 5 dimensions, with a total of 19 items, and each item is scored out of 100 points. The higher the score, the better the therapeutic effect
Measured: After 24 and 48 weeks of treatment
KCCQ-OS
Changes in Kansas City Cardiomyopathy Questionnaire overall score (KCCQ-OS) compared to baseline.The total score ranges from 0 to 100,higher scores mean a better outcome.
Measured: After 24 and 48 weeks of treatment
Echocardiography
Changes from baseline examined via echocardiography, including left ventricular systolic function (left ventricular end-diastolic diameter (LVDd), left ventricular end-systolic diameter (LVSd), left ventricular ejection fraction (LVEF), left ventricular fractional shortening (FS) and left ventricular diastolic function (E/A and E/e) . When possible, the left ventricular global longitudinal strain rate (LVGLS) was also measured
Measured: After 48 weeks of treatment
Metabolic equivalents(METs)
Changes in metabolic equivalents(METs) determined by cardiopulmonary exercise testing in some patients.
Measured: After 48 weeks of treatment
Anaerobic thresholds (ATs)
Changes in anaerobic thresholds (ATs) determined by cardiopulmonary exercise testing in some patients.
Measured: After 48 weeks of treatment
Maximal oxygen consumption (VO2max)
Changes in maximal oxygen consumption (VO2max) determined by cardiopulmonary exercise testing in some patients.
Measured: After 48 weeks of treatment
VO2/heart rate(HR)
Changes in VO2/HR determined by cardiopulmonary exercise testing in some patients.
Measured: After 48 weeks of treatment
The ratio of the change in VO2 to the change in the work rate (△VO2/△WR)
Changes in △VO2/△WR determined by cardiopulmonary exercise testing in some patients.
Measured: After 48 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start6 Nov 2025
- Primary completion31 Aug 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies 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
- None (open label)
- Enrolment
- 2,708 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SPH Qingdao Growful Pharmacetical Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110415
- Sponsor's protocol ID
- Growful2401YXS
- Acronym
- HEARTPOWER
- Status last verified
- Nov 2025
- First submitted
- 22 Jul 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vrints C, Andreotti F, Koskinas KC, Rossello X, Adamo M, Ainslie J, Banning AP, Budaj A, Buechel RR, Chiariello GA, Chieffo A, Christodorescu RM, Deaton C, Doenst T, Jones HW, Kunadian V, Mehilli J, Milojevic M, Piek JJ, Pugliese F, Rubboli A, Semb AG, Senior R, Ten Berg JM, Van Belle E, Van Craenenbroeck EM, Vidal-Perez R, Winther S; ESC Scientific Document Group. 2024 ESC Guidelines for the management of chronic coronary syndromes. Eur Heart J. 2024 Sep 29;45(36):3415-3537. doi: 10.1093/eurheartj/ehae177. No abstract available.
PubMed 39210710Li Y, Li Y, Zhang Z, Zhang J, Chen H, Yu H, Meng X, Yuan H, Shao L, Lu Y, Liu B, Xu J, Zhang Y, Li J, Han Y; HEARTRIP investigators. Efficacy and safety of yangxinshi versus trimetazidine on exercise tolerance in patients with coronary heart disease after percutaneous coronary intervention: Multicenter, double-blind clinical trial. Phytomedicine. 2024 Dec;135:156198. doi: 10.1016/j.phymed.2024.156198. Epub 2024 Nov 7.
PubMed 39566404Zhang S, Shen Y, Liu P, Meng X, Hu D. Yangxinshi Tablet Improves Exercise Capacity for Patients with Coronary Heart Disease: Results from a Randomized, Double-Blind, Placebo-Controlled, and Multicenter Trial. Rev Cardiovasc Med. 2022 Jul 21;23(8):266. doi: 10.31083/j.rcm2308266. eCollection 2022 Aug.
PubMed 39076617Rao SV, O'Donoghue ML, Ruel M, Rab T, Tamis-Holland JE, Alexander JH, Baber U, Baker H, Cohen MG, Cruz-Ruiz M, Davis LL, de Lemos JA, DeWald TA, Elgendy IY, Feldman DN, Goyal A, Isiadinso I, Menon V, Morrow DA, Mukherjee D, Platz E, Promes SB, Sandner S, Sandoval Y, Schunder R, Shah B, Stopyra JP, Talbot AW, Taub PR, Williams MS; Peer Review Committee Members. 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2025 Jun 10;85(22):2135-2237. doi: 10.1016/j.jacc.2024.11.009. Epub 2025 Feb 27.
PubMed 40013746
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Efficacy and Safety of Yangxinshi Tablets in the Treatment of Patients With Coronary Heart Disease Complicated by Cardiac Dysfunction
- ClinicalTrials.gov ID
- NCT07110415
- Acronym / sponsor ID
- HEARTPOWER / Growful2401YXS
- Conditions
- Coronary Heart Disease, Cardiac Dysfunction
- Keywords
- Yangxinshi, Coronary heart disease, Cardiac dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,708 participants (estimated)
- Lead sponsor
- SPH Qingdao Growful Pharmacetical Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2025 (actual)
- Primary completion
- 31 Aug 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 7 Aug 2025 (actual)
- 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.
A randomized controlled trial was conducted to evaluate the efficacy and safety of Yangxinshi tablets in improving the condition of patients with coronary heart disease complicated by cardiac dysfunction.
Detailed description
The purpose of this study was to investigate whether the addition of Yangxinshi tablets to conventional treatment can reduce the composite endpoint time, increase exercise tolerance, and improve quality of life and mental health in patients with coronary heart disease complicated by cardiac dysfunction. A total of 2708 eligible patients were randomly divided into two groups. In addition to conventional treatment, the trial group was given Yangxinshi tablets (3 tablets/time, 3 times/day), while the control group was a blank control. The treatment cycle continued until the expected number of endpoint events was reached or the study ended, whichever occurred first. The primary endpoint was the composite endpoint of ischemic events or heart failure-related clinical events (including all-cause death, ischemia-driven revascularization, stroke, myocardial infarction (MI), and readmission due to aggravated ACS or heart failure) during the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial group | Experimental | Drug: Yangxinshi tabletBasic treatment and Trial drug |
| Control group | Sham comparator | Drug: Blank controlBasic treatment |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- For inpatients diagnosed with coronary heart disease (including acute coronary syndrome and chronic coronary syndrome), it is up to the doctor to decide whether to undergo revascularization and what kind of revascularization to use.
- Patients aged between 40 and 80 years (inclusive), regardless of sex;
- Patients with NYHA cardiac function classes II-IV;
- Patients with NT-proBNP > 125 pg/mL (or BNP>35 pg/mL);
- The syndrome differentiation in traditional Chinese medicine conforms to chest obstruction (qi deficiency and blood stasis syndrome)
Key exclusion criteria (12 listed)
- Patients with STEMI within 3 days;
- Patients at extremely high risk of NSTEMI (hemodynamic instability, cardiogenic shock, new-onset heart failure or aggravated heart failure, severe ventricular arrhythmia)
- Patients with acute myocardial infarction complicated with cardiogenic shock, mechanical complications, respiratory failure and other multiple organ failure;
- Patients with severe liver dysfunction (transaminase levels more than three times the upper limit of normal), renal insufficiency (eGFR < 30mL/min/1.73m2), acute infectious diseases, and mental disorders;以上翻译结果来自有道神经网络翻译(YNMT)· 通用场景
- Patients with drug-resistant hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg);
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 |
|---|---|---|
| Yangxinshi tabletAlso: YangxinshiBasic treatment: All patients received a conventional treatment regimen, including outcome-improving drugs (aspirin, P2Y12 receptor inhibitor、β-blockers, statins, ARNI /ACEI/ARB, SGLT2i, and MRA) and symptom-relieving drugs (nitrates, calcium antagonists, and loop diuretic). Trial drug: Yangxinshi tablets, 3 tablets/3 times a day, taken orally | Drug | Trial group |
| Blank controlBasic treatment: All patients received a conventional treatment regimen, including outcome-improving drugs (aspirin, P2Y12 receptor inhibitor、β-blockers, statins, ARNI /ACEI/ARB, SGLT2i, and MRA) and symptom-relieving drugs (nitrates, calcium antagonists, and loop diuretic). Trial drug: Blank control | Drug | Control group |
Primary outcome
The composite endpoint was ischemic events or heart failure-related clinical events
Time frame: Through study completion, an average of 3 years
All-cause death, ischemia-driven revascularization, stroke, MI, and readmission due to aggravated ACS or heart failure
21 secondary outcomes
Ischemic composite endpoint events
Time frame: Through study completion, an average of 3 years
Heart failure-related clinical events
Time frame: Through study completion, an average of 3 years
Cardiovascular and cerebrovascular deaths
Time frame: Through study completion, an average of 3 years
All-cause death
Time frame: Through study completion, an average of 3 years
Readmission due to ACS
Time frame: Through study completion, an average of 3 years
Readmission due to aggravated heart failure
Time frame: Through study completion, an average of 3 years
The cumulative incidence of readmission due to aggravated ACS or heart failure
Time frame: Through study completion, an average of 3 years
Win ratio
Time frame: Through study completion, an average of 3 years
6MWD
Time frame: From baseline at 48 weeks
NT-proBNP or BNP
Time frame: From baseline at 48 weeks
Patient Health Questionnaire - 9(PHQ-9) depression scale
Time frame: After 24 and 48 weeks of treatment
Generalized Anxiety Disorder 7 - item Scale(GAD-7) anxiety scale
Time frame: After 24 and 48 weeks of treatment
NYHA
Time frame: After 24 and 48 weeks of treatment
SAQ
Time frame: After 24 and 48 weeks of treatment
KCCQ-OS
Time frame: After 24 and 48 weeks of treatment
Echocardiography
Time frame: After 48 weeks of treatment
Metabolic equivalents(METs)
Time frame: After 48 weeks of treatment
Anaerobic thresholds (ATs)
Time frame: After 48 weeks of treatment
Maximal oxygen consumption (VO2max)
Time frame: After 48 weeks of treatment
VO2/heart rate(HR)
Time frame: After 48 weeks of treatment
The ratio of the change in VO2 to the change in the work rate (△VO2/△WR)
Time frame: After 48 weeks of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Results publication: PubMed 39210710Vrints C, Andreotti F, Koskinas KC, Rossello X, Adamo M, Ainslie J, Banning AP, Budaj A, Buechel RR, Chiariello GA, Chieffo A, Christodorescu RM, Deaton C, Doenst T, Jones HW, Kunadian V, Mehilli J, Milojevic M, Piek JJ, Pugliese F, Rubboli A, Semb AG, Senior R, Ten Berg JM, Van Belle E, Van Craenenbroeck EM, Vidal-Perez R, Winther S; ESC Scientific Document Group. 2024 ESC Guidelines for the management of chronic coronary syndromes. Eur Heart J. 2024 Sep 29;45(36):3415-3537. doi: 10.1093/eurheartj/ehae177. No abstract available.
- Results publication: PubMed 39566404Li Y, Li Y, Zhang Z, Zhang J, Chen H, Yu H, Meng X, Yuan H, Shao L, Lu Y, Liu B, Xu J, Zhang Y, Li J, Han Y; HEARTRIP investigators. Efficacy and safety of yangxinshi versus trimetazidine on exercise tolerance in patients with coronary heart disease after percutaneous coronary intervention: Multicenter, double-blind clinical trial. Phytomedicine. 2024 Dec;135:156198. doi: 10.1016/j.phymed.2024.156198. Epub 2024 Nov 7.
- Results publication: PubMed 39076617Zhang S, Shen Y, Liu P, Meng X, Hu D. Yangxinshi Tablet Improves Exercise Capacity for Patients with Coronary Heart Disease: Results from a Randomized, Double-Blind, Placebo-Controlled, and Multicenter Trial. Rev Cardiovasc Med. 2022 Jul 21;23(8):266. doi: 10.31083/j.rcm2308266. eCollection 2022 Aug.
- Results publication: PubMed 40013746Rao SV, O'Donoghue ML, Ruel M, Rab T, Tamis-Holland JE, Alexander JH, Baber U, Baker H, Cohen MG, Cruz-Ruiz M, Davis LL, de Lemos JA, DeWald TA, Elgendy IY, Feldman DN, Goyal A, Isiadinso I, Menon V, Morrow DA, Mukherjee D, Platz E, Promes SB, Sandner S, Sandoval Y, Schunder R, Shah B, Stopyra JP, Talbot AW, Taub PR, Williams MS; Peer Review Committee Members. 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2025 Jun 10;85(22):2135-2237. doi: 10.1016/j.jacc.2024.11.009. Epub 2025 Feb 27.
- Individual participant dataSharing planned: No
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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.
96 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 Yangxinshi tablet in people with Coronary Heart Disease and Cardiac Dysfunction, run by SPH Qingdao Growful Pharmacetical Co.,Ltd at 96 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 12 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: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 96 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Han ya ling (024-28856114, hanyaling@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The composite endpoint was ischemic events or heart failure-related clinical events (time frame: Through study completion, an average of 3 years). 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 NCT07110415, which also lists 4 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 25 Nov 2025.