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

Official title

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

Overview

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.

Detailed 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.

Interventions

• Drug Yangxinshi tablet
  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
• Drug Blank control
  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

Primary outcome measures

• The composite endpoint was ischemic events or heart failure-related clinical events [Time frame: Through study completion, an average of 3 years]

Secondary outcome measures (12)

• Ischemic composite endpoint events [Time frame: Through study completion, an average of 3 years]
• Heart failure-related clinical events [Time frame: Through study completion, an average of 3 years]
• Cardiovascular and cerebrovascular deaths [Time frame: Through study completion, an average of 3 years]
• All-cause death [Time frame: Through study completion, an average of 3 years]
• Readmission due to ACS [Time frame: Through study completion, an average of 3 years]
• Readmission due to aggravated heart failure [Time frame: Through study completion, an average of 3 years]
• The cumulative incidence of readmission due to aggravated ACS or heart failure [Time frame: Through study completion, an average of 3 years]
• Win ratio [Time frame: Through study completion, an average of 3 years]
• 6MWD [Time frame: From baseline at 48 weeks]
• NT-proBNP or BNP [Time frame: From baseline at 48 weeks]
• Patient Health Questionnaire - 9(PHQ-9) depression scale [Time frame: After 24 and 48 weeks of treatment]
• Generalized Anxiety Disorder 7 - item Scale(GAD-7) anxiety scale [Time frame: After 24 and 48 weeks of treatment]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 96 centers

• The People's Hospital of Bozhou — Haozhou
• Beijing Hospital of Traditional Chinese Medicine — Beijing
• Dongfang Hospital,Beijing University of Chinese Medicine — Beijing
• Guang'anmen Hospital,China Academy of Chinese Medical Sciences — Beijing
• Army Specialty Medical Center — Chongqing
• Chongqing Emergency Medical Center — Chongqing
• Chongqing General Hospital — Chongqing
• Chongqing University Three Gorges Hospital — Chongqing
• … and 88 more centers

Publications

• Vrints C, Andreotti F, Koskinas KC, Rossello X, Adamo M, Ainslie J, Banning AP, Budaj A, Buechel RR, Chiariello GA, Chieffo A, Christodorescu RM, Deaton C, Doenst T, Jones HW, Kunadian V, Mehilli J, Milojevic M, Piek JJ, Pugliese F, Rubboli A, Semb AG, Senior R, Ten Berg JM, Van Belle E, Van Craenenbroeck EM, Vidal-Perez R, Winther S; ESC Scientific Document Group. 2024 ESC Guidelines for the mana PMID 39210710
• Li Y, Li Y, Zhang Z, Zhang J, Chen H, Yu H, Meng X, Yuan H, Shao L, Lu Y, Liu B, Xu J, Zhang Y, Li J, Han Y; HEARTRIP investigators. Efficacy and safety of yangxinshi versus trimetazidine on exercise tolerance in patients with coronary heart disease after percutaneous coronary intervention: Multicenter, double-blind clinical trial. Phytomedicine. 2024 Dec;135:156198. doi: 10.1016/j.phymed.2024.156 PMID 39566404
• Zhang S, Shen Y, Liu P, Meng X, Hu D. Yangxinshi Tablet Improves Exercise Capacity for Patients with Coronary Heart Disease: Results from a Randomized, Double-Blind, Placebo-Controlled, and Multicenter Trial. Rev Cardiovasc Med. 2022 Jul 21;23(8):266. doi: 10.31083/j.rcm2308266. eCollection 2022 Aug. PMID 39076617
• Rao SV, O'Donoghue ML, Ruel M, Rab T, Tamis-Holland JE, Alexander JH, Baber U, Baker H, Cohen MG, Cruz-Ruiz M, Davis LL, de Lemos JA, DeWald TA, Elgendy IY, Feldman DN, Goyal A, Isiadinso I, Menon V, Morrow DA, Mukherjee D, Platz E, Promes SB, Sandner S, Sandoval Y, Schunder R, Shah B, Stopyra JP, Talbot AW, Taub PR, Williams MS; Peer Review Committee Members. 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideli PMID 40013746

Identifiers

NCT: NCT07110415 · Growful2401YXS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗