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

ConditionsCoronary Heart Disease Cardiac Dysfunction

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age40-80

SponsorSPH Qingdao Growful Pharmacetical Co.,Ltd

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Yangxinshi tablet
Drug
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
Blank control
Drug
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

Treatment groups

2,708 Participants

are divided into 2 treatment groups

Group A: Trial groupExperimental treatment 1 intervention

Group B: Control groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

The composite endpoint was ischemic events or heart failure-related clinical events

All-cause death, ischemia-driven revascularization, stroke, MI, and readmission due to aggravated ACS or heart failure

Time frame