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

Recruiting now · Phase 4

Conditions studied: Coronary Heart Disease, Cardiac Dysfunction

In brief

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.

Key facts

Study ID

NCT07110415

Run by

SPH Qingdao Growful Pharmacetical Co.,Ltd

People needed

2708

Starts

2025-11-06

Expected to finish

2030-12-31

Last updated by the study team

2025-11-25

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• General Hospital of Northern Theater Command — Shenyang, Liaoning, China (enrolling)
• Dongfang Hospital,Beijing University of Chinese Medicine — Beijing, Beijing Municipality, China
• Liuzhou People's Hospital — Liuzhou, Guangxi, 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
• Guang'anmen Hospital,China Academy of Chinese Medical Sciences — Beijing, Beijing Municipality, 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
• Beijing Hospital of Traditional Chinese Medicine — Beijing, Beijing Municipality, China

Full record on ClinicalTrials.gov

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