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

SPH Qingdao Growful Pharmacetical Co.,Ltd

Status and phase: Enrolling; Phase 4

Conditions: Cardiac Dysfunction; Coronary Heart Disease

Treatments: Drug: Blank control; Drug: Yangxinshi tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT07110415

Growful2401YXS

Details and patient eligibility

About

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.

Full description

The purpose of this study was to investigate whether the addition of Yangxinshi tablets to conventional treatment can reduce the composite endpoint time, increase exercise tolerance, and improve quality of life and mental health in patients with coronary heart disease complicated by cardiac dysfunction. A total of 2708 eligible patients were randomly divided into two groups. In addition to conventional treatment, the trial group was given Yangxinshi tablets (3 tablets/time, 3 times/day), while the control group was a blank control. The treatment cycle continued until the expected number of endpoint events was reached or the study ended, whichever occurred first. The primary endpoint was the composite endpoint of ischemic events or heart failure-related clinical events (including all-cause death, ischemia-driven revascularization, stroke, myocardial infarction (MI), and readmission due to aggravated ACS or heart failure) during the study period.

Enrollment: 2,708 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,708 participants in 2 patient groups

Trial group

Experimental group

Description:

Basic treatment and Trial drug

Treatment:

Drug: Yangxinshi tablet

Control group

Sham Comparator group

Description:

Basic treatment

Treatment:

Drug: Blank control