Yangxinshi tablets for people with coronary heart disease and heart dysfunction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• General Hospital of Northern Theater Command
  Shenyang, Liaoning, China Recruiting
• 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

+46 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Han ya ling
• Email: hanyaling@263.net
• Phone: 024-28856114

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.