Efficacy and Safety Trials of Yangxinshi Tablets in the Treatment of Patients With Coronary Heart Disease Complicated by Cardiac Dysfunction
HEARTPOWER
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
1 other identifier
interventional
2,708
1 country
96
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2025
Longer than P75 for phase_4
96 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2025
CompletedFirst Posted
Study publicly available on registry
August 7, 2025
CompletedStudy Start
First participant enrolled
November 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
November 25, 2025
November 1, 2025
4.8 years
July 22, 2025
November 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Through study completion, an average of 3 years
Secondary Outcomes (21)
Ischemic composite endpoint events
Through study completion, an average of 3 years
Heart failure-related clinical events
Through study completion, an average of 3 years
Cardiovascular and cerebrovascular deaths
Through study completion, an average of 3 years
All-cause death
Through study completion, an average of 3 years
Readmission due to ACS
Through study completion, an average of 3 years
- +16 more secondary outcomes
Other Outcomes (11)
Heart rate
After 24 and 48 weeks of treatment
Blood pressure
After 24 and 48 weeks of treatment
12-lead Electrocardiogram (ECG)
After 24 and 48 weeks of treatment
- +8 more other outcomes
Study Arms (2)
Trial group
EXPERIMENTALBasic treatment and Trial drug
Control group
SHAM COMPARATORBasic treatment
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (96)
The People's Hospital of Bozhou
Haozhou, Anhui, China
Beijing Hospital of Traditional Chinese Medicine
Beijing, Beijing Municipality, China
Dongfang Hospital,Beijing University of Chinese Medicine
Beijing, Beijing Municipality, China
Guang'anmen Hospital,China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
Army Specialty Medical Center
Chongqing, Chongqing Municipality, China
Chongqing Emergency Medical Center
Chongqing, Chongqing Municipality, China
Chongqing General Hospital
Chongqing, Chongqing Municipality, China
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, China
The Southwest Hospital of Amu
Chongqing, Chongqing Municipality, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
The affiliated traditional Chinese medicine hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
The first affiliated hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The Second Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, China
The Fifth Affiliated Hospital,Sun Yat-sen University
Zhuhai, Guangdong, China
The First Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
Liuzhou People's Hospital
Liuchow, Guangxi, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
The First Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
The First Affiliated Hospital of Zunyi Medical University"
Zunyi, Guizhou, China
Baoding No.1 Central Hospital
Baoding, Hebei, China
Jingjiang People's Hospital
Cangzhou, Hebei, China
Handan Central Hospital
Handan, Hebei, China
Hebei General Hospital
Shijiazhuang, Hebei, China
Xingtai People's Hospital
Xingtai, Hebei, China
The First Affiliated Hospital of Hebei North University
Zhangjiakou, Hebei, China
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China
The First Affiliated Hospital of Harbin Medical University
Haerbin, Heilongjiang, China
The Second Affiliated Hospital of Harbin Medical University
Haerbin, Heilongjiang, China
HeGang People's Hospital
Hegang, Heilongjiang, China
Mudanjiang Cardiovascular Disease Hospital
Mudanjiang, Heilongjiang, China
The 7th People's Hospital of Zhengzhou
Zhengzhou, Henan, China
The Third People's Hospital of Zhengzhou
Zhengzhou, Henan, China
Hunan Provincial TCM Hospital
Changsha, Hunan, China
Yiyang Central Hospital
Yiyang, Hunan, China
Xuyi People's Hospital
Huai'an, Jiangsu, China
Nanjing Lishui People's Hospital
Nanjing, Jiangsu, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
Jiangsu Provincial People's Hospital Suqian Branch
Suqian, Jiangsu, China
Taizhou Fourth People's Hospital
Taizhou, Jiangsu, China
Xuzhou No.1 People's Hospital
Xuzhou, Jiangsu, China
Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Changchun, Jilin, China
Jilin Provincial People's Hospital
Changchun, Jilin, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
The Second Norman Bethune Hospital of Jilin University
Changchun, Jilin, China
Jilin People's Hospital
Jilin, Jilin, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Dandong Central Hospital
Dandong, Liaoning, China
Fushun Central Hospital
Fushun, Liaoning, China
Fuxin Central Hospital
Fuxin, Liaoning, China
General Hospital of Northern Theater Command
Shenyang, Liaoning, 110016, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
The Fourth Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Chifeng Municipal Hospital
Chifeng, Neimenggu, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shandong University of Traditional Chinese Medicine Affiliated Hospital
Jinan, Shandong, China
The 960th Hospital of the PLA Joint Logistics Support Force
Jinan, Shandong, China
The Fourth People's Hospital of Jinan
Jinan, Shandong, China
The Second People's Hospital of Liaocheng
Liaocheng, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Tengzhou Central People's Hospital
Tengzhou, Shandong, China
Affiliated Hospital of Shandong Second Medical University
Weifang, Shandong, China
PLA Joint Logistics Support Force No.970 Hospital
Yantai, Shandong, China
Yantai Affiliated Hospital of Binzhou Medical University
Yantai, Shandong, China
Fudan University Minhang Hospital
Shanghai, Shanghai Municipality, China
Ruijin Hospital Luban Branch, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Xi'an Gaoling District Hospital
Xi’an, Shanxi, China
The Eighth Affiliated Hospital,Sun Yat-sen University
Shenzhen, Shenzhen, China
Chengdu Wenjiang District People's Hospital
Chengdu, Sichuan, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Guang'an People's Hospital
Guang’an, Sichuan, China
The People's Hospital of Jianyang City
Jiancheng, Sichuan, China
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, China
Tianjin Fifth Center Hospital
Tianjin, Tianjin Municipality, China
Tianjin Hospital of Integrated Traditional Chinese and Western Medicine
Tianjin, Tianjin Municipality, China
Yunnan Provincial Hospital of Traditional Chinese Medicine
Kunming, Yunnan, China
Affiliated Hangzhou First People's Hospital,School of Medicine,Westlake University
Hangzhou, Zhejiang, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Huzhou Central Hospital
Huzhou, Zhejiang, China
The First Hospital of Jiaxing
Jiaxing, Zhejiang, China
The Second Hospital of Jiaxing
Jiaxing, Zhejiang, China
Beilun Branch of the First Affiliated Hospital of Zhejiang University School of Medicine
Ningbo, Zhejiang, China
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China
The Affiliated People'sHospital of Ningbo University
Ningbo, Zhejiang, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Shaoxing, Zhejiang, China
Taizhou Central Hospital
Taizhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
Yantai Yuhuangding Hospital
Yantai, China
Related Publications (4)
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.
PMID: 39210710RESULTLi 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.
PMID: 39566404RESULTZhang 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.
PMID: 39076617RESULTRao 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.
PMID: 40013746RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2025
First Posted
August 7, 2025
Study Start
November 6, 2025
Primary Completion (Estimated)
August 31, 2030
Study Completion (Estimated)
December 31, 2030
Last Updated
November 25, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share