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

Phase 4RecruitingNCT07110415

SPH Qingdao Growful Pharmacetical Co.,Ltd2,708 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

2,708

Conditions

Coronary Heart Disease Cardiac Dysfunction

Interventions

Yangxinshi tabletDRUG

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 controlDRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (96)

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: Through study completion, an average of 3 years

Secondary Outcomes

Ischemic composite endpoint events

Cardiovascular and cerebrovascular death, MI, ischemia-driven revascularization, stroke, and readmission due to ACS

Time frame: Through study completion, an average of 3 years

Heart failure-related clinical events

Readmission due to aggravated heart failure or all-cause death

Time frame: Through study completion, an average of 3 years

Cardiovascular and cerebrovascular deaths

Occurrence of cardiovascular and cerebrovascular deaths

Time frame: Through study completion, an average of 3 years

All-cause death

Occurrence of 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

Central Contacts

Han ya ling

CONTACT

024-28856114 hanyaling@263.net

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

Chongqing Emergency Medical Center

Chongqing, Chongqing Municipality, China

NOT_YET_RECRUITING

Chongqing General Hospital

Chongqing, Chongqing Municipality, China

NOT_YET_RECRUITING

Chongqing University Three Gorges Hospital

Chongqing, Chongqing Municipality, China

NOT_YET_RECRUITING

The Southwest Hospital of Amu

Chongqing, Chongqing Municipality, China

NOT_YET_RECRUITING

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

NOT_YET_RECRUITING

...and 86 more locations

The joint gamma frailty model was adopted for analysis

Time frame: Through study completion, an average of 3 years

Win ratio

The main efficacy indicators were analyzed by using the win ratio method

Time frame: Through study completion, an average of 3 years

6MWD

Change in 6-minute walking distance

Time frame: From baseline at 48 weeks

NT-proBNP or BNP

Measurement of NT-proBNP or BNP, calculation of the proportion of patients achieving NT-proBNP \<125 pg/mL (or BNP \<35 pg/mL), and the degree of reduction

Time frame: From baseline at 48 weeks

Patient Health Questionnaire - 9(PHQ-9) depression scale

The Patient Health Questionnaire - 9(PHQ-9)depression scale comprises nine questions. In each assessment area, scores range from 0 to 3 based on the increasing frequency of difficult: 0 indicates "not at all," 1 indicates "sometimes," 2 indicates "more than half the time," and 3 indicates "almost every day." The total score ranges from 0 to 27,higher scores mean a worse outcome.

Time frame: After 24 and 48 weeks of treatment

Generalized Anxiety Disorder 7 - item Scale(GAD-7) anxiety scale

The Generalized Anxiety Disorder 7 - item Scale(GAD-7) anxiety scale comprises seven questions. In each assessment area, scores range from 0 to 3 based on the increasing frequency of difficult: 0 indicates "not at all," 1 indicates "sometimes," 2 indicates "more than half the time," and 3 indicates "almost every day." The total score ranges from 0 to 21,higher scores mean a worse outcome.

Time frame: After 24 and 48 weeks of treatment

NYHA

Changes in New York Heart Association (NYHA) functional classification

Time frame: After 24 and 48 weeks of treatment

SAQ

Changes in Seattle Angina Questionnaire (SAQ) scores.The SAQ scale is divided into 5 dimensions, with a total of 19 items, and each item is scored out of 100 points. The higher the score, the better the therapeutic effect

Time frame: After 24 and 48 weeks of treatment

KCCQ-OS

Changes in Kansas City Cardiomyopathy Questionnaire overall score (KCCQ-OS) compared to baseline.The total score ranges from 0 to 100,higher scores mean a better outcome.

Time frame: After 24 and 48 weeks of treatment

Echocardiography

Changes from baseline examined via echocardiography, including left ventricular systolic function (left ventricular end-diastolic diameter (LVDd), left ventricular end-systolic diameter (LVSd), left ventricular ejection fraction (LVEF), left ventricular fractional shortening (FS) and left ventricular diastolic function (E/A and E/e) . When possible, the left ventricular global longitudinal strain rate (LVGLS) was also measured

Time frame: After 48 weeks of treatment

Metabolic equivalents(METs)

Changes in metabolic equivalents(METs) determined by cardiopulmonary exercise testing in some patients.

Time frame: After 48 weeks of treatment

Anaerobic thresholds (ATs)

Changes in anaerobic thresholds (ATs) determined by cardiopulmonary exercise testing in some patients.

Time frame: After 48 weeks of treatment

Maximal oxygen consumption (VO2max)

Changes in maximal oxygen consumption (VO2max) determined by cardiopulmonary exercise testing in some patients.

Time frame: After 48 weeks of treatment

VO2/heart rate(HR)

Changes in VO2/HR determined by cardiopulmonary exercise testing in some patients.

Time frame: After 48 weeks of treatment

The ratio of the change in VO2 to the change in the work rate (△VO2/△WR)

Changes in △VO2/△WR determined by cardiopulmonary exercise testing in some patients.

Time frame: After 48 weeks of treatment