Yangxinshi tablets for people with coronary heart disease and heart dysfunction

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

This trial tests whether adding Yangxinshi tablets to usual care helps people aged 40–80 with coronary heart disease and cardiac dysfunction have fewer heart-related events and better exercise tolerance and quality of life.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2708 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: SPH Qingdao Growful Pharmacetical Co.,Ltd (Industry-sponsored)
• Locations: 96 sites (Haozhou, Anhui and 95 other locations)
• Trial ID: NCT07110415 on ClinicalTrials.gov

What this trial studies

This randomized, controlled Phase 4 trial enrolled 2,708 patients with coronary heart disease complicated by cardiac dysfunction and elevated NT‑proBNP, randomizing them to Yangxinshi tablets plus conventional treatment or to conventional treatment alone (blank control). The intervention group received Yangxinshi three tablets three times daily until the expected number of endpoint events was reached or the study ended. The primary outcome is a composite of ischemic or heart failure–related clinical events (all‑cause death, ischemia‑driven revascularization, stroke, myocardial infarction, and readmission for aggravated ACS or heart failure); secondary outcomes include exercise tolerance, quality of life, and mental health measures. Enrollment required NYHA class II–IV and a TCM diagnosis of chest obstruction (qi deficiency and blood stasis) in addition to standard medical eligibility criteria.

Who should consider this trial

Good fit: Ideal candidates are adults 40–80 years old with coronary heart disease and NYHA class II–IV cardiac dysfunction, elevated NT‑proBNP (or BNP), the specified TCM syndrome, and willingness to consent and attend study visits at an enrolling site.

Not a fit: Patients with very recent STEMI (within 3 days), those with unstable or extremely high‑risk NSTEMI, cardiogenic shock, severe ventricular arrhythmia, or who do not meet the trial's age, biomarker, or TCM syndrome criteria are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the treatment could reduce major ischemic and heart‑failure events and improve exercise capacity and quality of life for affected patients.

How similar studies have performed: Some smaller trials of traditional Chinese medicine formulations have reported symptomatic or functional benefits, but large randomized outcome trials demonstrating reductions in major cardiac events are limited.

Eligibility criteria

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.

Where this trial is running

Haozhou, Anhui and 95 other locations

• The People's Hospital of Bozhou — Haozhou, Anhui, China (Not_yet_recruiting)
• Beijing Hospital of Traditional Chinese Medicine — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Dongfang Hospital,Beijing University of Chinese Medicine — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Guang'anmen Hospital,China Academy of Chinese Medical Sciences — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Army Specialty Medical Center — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• Chongqing Emergency Medical Center — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• Chongqing General Hospital — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• Chongqing University Three Gorges Hospital — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• The Southwest Hospital of Amu — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• The First Hospital of Lanzhou University — Lanzhou, Gansu, China (Not_yet_recruiting)
• The affiliated traditional Chinese medicine hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• The first affiliated hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Shantou University Medical College — Shantou, Guangdong, China (Not_yet_recruiting)
• The Fifth Affiliated Hospital,Sun Yat-sen University — Zhuhai, Guangdong, China (Not_yet_recruiting)
• The First Affiliated Hospital of Guilin Medical University — Guilin, Guangxi, China (Not_yet_recruiting)
• Liuzhou People's Hospital — Liuzhou, Guangxi, China (Not_yet_recruiting)
• The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China (Not_yet_recruiting)
• The People's Hospital of Guangxi Zhuang Autonomous Region — Nanning, Guangxi, China (Not_yet_recruiting)
• The First Affiliated Hospital of Guizhou Medical University — Guiyang, Guizhou, China (Not_yet_recruiting)
• The First Affiliated Hospital of Zunyi Medical University" — Zunyi, Guizhou, China (Not_yet_recruiting)
• Baoding No.1 Central Hospital — Baoding, Hebei, China (Not_yet_recruiting)
• Jingjiang People's Hospital — Cangzhou, Hebei, China (Not_yet_recruiting)
• Handan Central Hospital — Handan, Hebei, China (Not_yet_recruiting)
• Hebei General Hospital — Shijiazhuang, Hebei, China (Not_yet_recruiting)
• Xingtai People's Hospital — Xingtai, Hebei, China (Not_yet_recruiting)
• The First Affiliated Hospital of Hebei North University — Zhangjiakou, Hebei, China (Not_yet_recruiting)
• Daqing Oilfield General Hospital — Daqing, Heilongjiang, China (Not_yet_recruiting)
• The First Affiliated Hospital of Harbin Medical University — Haerbin, Heilongjiang, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Harbin Medical University — Haerbin, Heilongjiang, China (Not_yet_recruiting)
• HeGang People's Hospital — Hegang, Heilongjiang, China (Not_yet_recruiting)
• Mudanjiang Cardiovascular Disease Hospital — Mudanjiang, Heilongjiang, China (Not_yet_recruiting)
• The 7th People's Hospital of Zhengzhou — Zhengzhou, Henan, China (Not_yet_recruiting)
• The Third People's Hospital of Zhengzhou — Zhengzhou, Henan, China (Not_yet_recruiting)
• Hunan Provincial TCM Hospital — Changsha, Hunan, China (Not_yet_recruiting)
• Yiyang Central Hospital — Yiyang, Hunan, China (Not_yet_recruiting)
• Xuyi People's Hospital — Huai'an, Jiangsu, China (Not_yet_recruiting)
• Nanjing Lishui People's Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• Zhongda Hospital Southeast University — Nanjing, Jiangsu, China (Not_yet_recruiting)
• Jiangsu Provincial People's Hospital Suqian Branch — Suqian, Jiangsu, China (Not_yet_recruiting)
• Taizhou Fourth People's Hospital — Taizhou, Jiangsu, China (Not_yet_recruiting)
• Xuzhou No.1 People's Hospital — Xuzhou, Jiangsu, China (Not_yet_recruiting)
• Affiliated Hospital of Changchun University of Traditional Chinese Medicine — Changchun, Jilin, China (Not_yet_recruiting)
• Jilin Provincial People's Hospital — Changchun, Jilin, China (Not_yet_recruiting)
• The First Bethune Hospital of Jilin University — Changchun, Jilin, China (Not_yet_recruiting)
• The Second Norman Bethune Hospital of Jilin University — Changchun, Jilin, China (Not_yet_recruiting)
• Jilin People's Hospital — Jilin, Jilin, China (Not_yet_recruiting)
• The First Affiliated Hospital of Dalian Medical University — Dalian, Liaoning, China (Not_yet_recruiting)
• Dandong Central Hospital — Dandong, Liaoning, China (Not_yet_recruiting)
• Fushun Central Hospital — Fushun, Liaoning, China (Not_yet_recruiting)
• Fuxin Central Hospital — Fuxin, Liaoning, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Han ya ling

Conditions Coronary Heart Disease; Cardiac Dysfunction; Yangxinshi; Coronary heart disease; Cardiac dysfunction