Efficacy and Safety Trials of Yangxinshi Tablets in the T... | NCT07110415

Status Module

Description Module

Arms/Interventions Module

Label	Type	Description	Intervention Names
Trial group	Experimental	Basic treatment and Trial drug	Drug: Yangxinshi tablet
Control group	Sham Comparator	Basic treatment	Drug: Blank control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	Through study completion, an average of 3 years

Secondary Outcomes

Measure	Description	Time Frame
Ischemic composite endpoint events	Cardiovascular and cerebrovascular death, MI, ischemia-driven revascularization, stroke, and readmission due to ACS	Through study completion, an average of 3 years
Heart failure-related clinical events

Measure	Description	Time Frame
Heart rate	Unit: beats /minute	After 24 and 48 weeks of treatment
Blood pressure	Systolic and diastolic,unit: mmHg	After 24 and 48 weeks of treatment

Eligibility Module

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.

Name	Role	Phone	Extension	Email
Han ya ling	Contact	024-28856114		hanyaling@263.net

Facility	Status	City	State	ZIP	Country	Contacts
The People's Hospital of Bozhou	Not yet recruiting	Haozhou	Anhui		China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39210710	Result	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 management of chronic coronary syndromes. Eur Heart J. 2024 Sep 29;45(36):3415-3537. doi: 10.1093/eurheartj/ehae177. No abstract available.
39566404

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases