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RECRUITING

NCT07110415

PHASE4

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

Sponsor: SPH Qingdao Growful Pharmacetical Co.,Ltd

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

2708

Start Date

2025-11-06

Completion Date

2030-12-31

Last Updated

2025-11-25

Healthy Volunteers

Conditions

Coronary Heart Disease Cardiac Dysfunction

Interventions

DRUG

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

DRUG

Blank control

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.

Locations (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, 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