Effect of Guanxinning Tablet on Coronary Microcirculation After Primary Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction

실험적: GXNT treatment group

Immediately after PPCI, the patient was given a loading dose of 4 tablets of Guanxinning Tablets, and then 4 tablets of Guanxinning Tablets were given tid for maintenance treatment, along with standard secondary prevention treatment for coronary heart disease.

의약품: Guanxinning Tablet(GXNT)

Guanxinning Tablets (2015), an established treatment for stable exertional angina (Grades I-II) with TCM-diagnosed heart-blood stasis syndrome, demonstrates proven safety/efficacy. Its active components (e.g., tanshinone IIA, salvianolic acid B, tetramethylpyrazine) from Salvia miltiorrhiza and Ligusticum chuanxiong exert:

Anti-atherosclerotic effects via:

Anti-inflammation & anti-LDL oxidation Endothelial improvement VSMC proliferation/migration inhibition Anti-platelet aggregation

Microvascular protection through:

Anti-apoptosis & autophagy regulation Platelet adhesion inhibition Reduced inflammatory factor release

위약 비교기: standard treatment group

Immediately after PPCI, the patient was given a loading dose of 4 tablets of placebo, and then 4 tablets of placebo were given tid for maintenance treatment, along with standard secondary prevention treatment for coronary heart disease.

의약품: Placebo

In this study, the placebo used in the placebo control group was completely consistent with the Guanxinning Tablets (GXNT) used in the experimental group in terms of appearance, including color, shape, size, gloss, odor, bitterness, dissolution rate, and packaging.

△IMH volume (%)

The change in the percentage of intramyocardial hemorrhage (IMH) volume relative to ventricular volume in the IRA-supplied myocardial territory, measured by CMR at the 6-month follow-up.

incidence of IMH (%)

Change in the incidence of IMH in the IRA-supplied myocardial territory measured by CMR at 6 months.

△MVO volume (%)

Change in the percentage of microvascular obstruction (MVO) volume in the IRA-supplied myocardial territory measured by CMR at 6 months.

incidence of MVO (%)

Change in the incidence of MVO in the IRA-supplied myocardial territory measured by CMR at 6 months.

myocardial infarct size (/ventricular volume, %)

Change in myocardial infarct size (/ventricular volume,%) measured by CMR at 6 months.

myocardial edema volume (/ventricular volume, %)

Change in percentage of myocardial edema volume (/ventricular volume, %) measured by CMR at 6 months.

△LVEF (%)

Change in left ventricular ejection fraction (LVEF) measured by echocardiography at 6 months.

CCS Angina Classification change

Change in Canada Cardiovascular Society Angina Classification score at 6 months.

Class I: Ordinary physical activity, such as walking and climbing stairs, does not cause angina. Angina occurs with strenuous, rapid, or prolonged exertion at work or recreation.

Class II: Slight limitation of ordinary activity. Angina occurs on walking or climbing stairs rapidly, walking uphill, walking or stair - climbing after meals, in cold, in wind, or under emotional stress. Angina occurs on walking more than two blocks on the level and climbing more than one flight of ordinary stairs at a normal pace.

Class III: Marked limitation of ordinary physical activity. Angina occurs on walking one to two blocks on the level and climbing one flight of stairs at a normal pace.

Class IV: Inability to carry on any physical activity without discomfort. Angina may be present at rest.

The lowest CCS angina pectoris score is grade I, and the highest is grade IV. The higher the grade, the worse the outcome.

TCM blood stasis pattern score change

Change in traditional Chinese medicine (TCM) syndrome score for blood stasis pattern at 6 months.

• Main Index: Fixed location of chest pain(10 score); Purple or dark - colored tongue(10); Ecchymosis and petechiae on the tongue(10); oronary angiography shows that at least one coronary artery is stenosed ≥ 75%(9); Ultrasound or angiography shows coronary artery thrombosis or intracardiac mural thrombosis(8); ②Secondary Index: Chest pain worsens at night(6); Purple - dark lips or gums(7); Varicose sublingual veins or purple - dark color(7); CAG shows that at least one coronary artery is stenosed ≥ 50% but < 75%(6); Shortening of APTT or PT(5); ③Auxiliary Index: Dark - black complexion(2); Stringy pulse(4); CCTA or CAG shows obvious vascular calcification or diffuse lesions(3); Elevated fibrinogen (3); The maximum value is 80, the minimum is not clearly defined as it depends on the combination of positive indexes; The higher the score, the more severe the symptom as well as the outcome.

circulating inflammatory markers absolute change(oxidized LDL, mmol/L)

absolute changes in circulating inflammatory markers: oxidized LDL(mmol/L) at 6 months

circulating inflammatory markers absolute change (IL-6, pg/mL)

absolute changes in circulating inflammatory markers: IL-6(pg/mL) at 6 months

circulating inflammatory markers absolute change (hsCRP, mg/L)

absolute changes in circulating inflammatory markers hsCRP(mg/L) at 6 months

diabetes markers absolute change (HbA1c, %)

absolute changes in diabetes markers: HbA1c(%) at 6 months

diabetes markers absolute change (FBG, fasting blood glucose, mmol/L)

absolute changes in diabetes markers: FBG, fasting blood glucose, (mmol/L) at 6 months

diabetes markers absolute change of GSP, Glycated serum protein (%)

absolute changes in diabetes markers: GSP, Glycated serum protein (%) at 6 months

Safety Outcomes

Composite endpoint including all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, ischemia-driven repeat revascularization, rehospitalization for heart failure, and any drug-related adverse reactions.