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Clinical Trials in China / NCT07110415
Recruiting Phase 4

Efficacy and Safety Trials of Yangxinshi Tablets in the Treatment of Patients With Coronary Heart Disease Complicated by Cardiac Dysfunction

NCT07110415 · tracked via the Priya Life Science China tracker
Sponsor
SPH Qingdao Growful Pharmacetical Co.,Ltd
Phase
Phase 4
Started
2025-11-06
Last updated
2025-11-25

Condition(s) studied

Coronary Heart DiseaseCardiac Dysfunction

Investigational drug(s) / intervention(s)

Yangxinshi tabletBlank control

Yangxinshi tablet: 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 control: 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 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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. 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. 2. Patients aged between 40 and 80 years (inclusive), regardless of sex; 3. Patients with NYHA cardiac function classes II-IV; 4. Patients with NT-proBNP \> 125 pg/mL (or BNP\>35 pg/mL); 5. The syndrome differentiation in traditional Chinese medicine conforms to chest obstruction (qi deficiency and blood stasis syndrome) 6. Patients who voluntarily participated and signed an informed consent form. Exclusion Criteria: 1. Patients with STEMI within 3 days; 2. Patients at extremely high risk of NSTEMI (hemodynamic instability, cardiogenic shock, new-onset heart failure or aggravated heart failure, severe ventricular arrhythmia) 3. Patients with acute myocardial infarction complicated with cardiogenic shock, mechanical complications, respiratory failure and other multiple organ failure; 4. 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 5. Patients with drug-resistant hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg); 6. Pregnant or lactating women, or those planning pregnancy during the study period; 7. Patients who cannot tolerate 3 months of dual antiplatelet therapy; 8. Patients with allergic reactions or abnormal drug reactions to the study drug or any of its excipients; 9. 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; 10. Patients who have participated in other clinical drug trials within the last three months; 11. Patients with malignant tumors and other pathological conditions with an expected survival of less than 3 years; 12. Patients whom the investigator deems unsuitable for participating in the clinical trial.

Primary outcome measure(s)

Trial sites (96)

FacilityCityRegionStatus
The People's Hospital of Bozhou Haozhou Anhui Not Yet Recruiting
Beijing Hospital of Traditional Chinese Medicine Beijing Beijing Municipality Not Yet Recruiting
Dongfang Hospital,Beijing University of Chinese Medicine Beijing Beijing Municipality Not Yet Recruiting
Guang'anmen Hospital,China Academy of Chinese Medical Sciences Beijing Beijing Municipality Not Yet Recruiting
Army Specialty Medical Center Chongqing Chongqing Municipality Not Yet Recruiting
Chongqing Emergency Medical Center Chongqing Chongqing Municipality Not Yet Recruiting
Chongqing General Hospital Chongqing Chongqing Municipality Not Yet Recruiting
Chongqing University Three Gorges Hospital Chongqing Chongqing Municipality Not Yet Recruiting
The Southwest Hospital of Amu Chongqing Chongqing Municipality Not Yet Recruiting
The First Hospital of Lanzhou University Lanzhou Gansu Not Yet Recruiting
The affiliated traditional Chinese medicine hospital of Guangzhou Medical University Guangzhou Guangdong Not Yet Recruiting
The first affiliated hospital, Sun Yat-sen University Guangzhou Guangdong Not Yet Recruiting
The Second Affiliated Hospital of Shantou University Medical College Shantou Guangdong Not Yet Recruiting
The Fifth Affiliated Hospital,Sun Yat-sen University Zhuhai Guangdong Not Yet Recruiting
The First Affiliated Hospital of Guilin Medical University Guilin Guangxi Not Yet Recruiting
Liuzhou People's Hospital Liuzhou Guangxi Not Yet Recruiting
The First Affiliated Hospital of Guangxi Medical University Nanning Guangxi Not Yet Recruiting
The People's Hospital of Guangxi Zhuang Autonomous Region Nanning Guangxi Not Yet Recruiting
The First Affiliated Hospital of Guizhou Medical University Guiyang Guizhou Not Yet Recruiting
The First Affiliated Hospital of Zunyi Medical University" Zunyi Guizhou Not Yet Recruiting
Baoding No.1 Central Hospital Baoding Hebei Not Yet Recruiting
Jingjiang People's Hospital Cangzhou Hebei Not Yet Recruiting
Handan Central Hospital Handan Hebei Not Yet Recruiting
Hebei General Hospital Shijiazhuang Hebei Not Yet Recruiting
Xingtai People's Hospital Xingtai Hebei Not Yet Recruiting
The First Affiliated Hospital of Hebei North University Zhangjiakou Hebei Not Yet Recruiting
Daqing Oilfield General Hospital Daqing Heilongjiang Not Yet Recruiting
The First Affiliated Hospital of Harbin Medical University Haerbin Heilongjiang Not Yet Recruiting
The Second Affiliated Hospital of Harbin Medical University Haerbin Heilongjiang Not Yet Recruiting
HeGang People's Hospital Hegang Heilongjiang Not Yet Recruiting
Mudanjiang Cardiovascular Disease Hospital Mudanjiang Heilongjiang Not Yet Recruiting
The 7th People's Hospital of Zhengzhou Zhengzhou Henan Not Yet Recruiting
The Third People's Hospital of Zhengzhou Zhengzhou Henan Not Yet Recruiting
Hunan Provincial TCM Hospital Changsha Hunan Not Yet Recruiting
Yiyang Central Hospital Yiyang Hunan Not Yet Recruiting
Xuyi People's Hospital Huai'an Jiangsu Not Yet Recruiting
Nanjing Lishui People's Hospital Nanjing Jiangsu Not Yet Recruiting
Zhongda Hospital Southeast University Nanjing Jiangsu Not Yet Recruiting
Jiangsu Provincial People's Hospital Suqian Branch Suqian Jiangsu Not Yet Recruiting
Taizhou Fourth People's Hospital Taizhou Jiangsu Not Yet Recruiting

+ 56 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07110415 on ClinicalTrials.gov ↗ ← All trials in China