Efficacy and Safety Trials of Yangxinshi Tablets in the Treatment of Patients With Coronary Heart Disease Complicated by Cardiac 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
SPH Qingdao Growful Pharmacetical Co.,Ltd
2,708 participants
Nov 6, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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.
Exclusion Criteria12
- 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.
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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
Locations(96)
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NCT07110415