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

A Randomized Explorative Pre-trial of the Effect of Guanxinning Tablet on Coronary Microcirculation After Primary Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction

①Research objective: In a small sample population, through the pre - experimental method, explore and evaluate the effect of Guanxinning tablets on the coronary microcirculation after primary percutaneous coronary intervention (PPCI) in patients with acute ST - segment elevation myocardial infarction (STEMI), with the change in the percentage of intramyocardial hemorrhage (IMH) in ventricular mass measured by cardiac magnetic resonance (CMR) imaging as the primary endpoint.

②Research significance: The research results of this project will provide preliminary theoretical basis and methodological support for the formal randomized controlled study on evaluating the effect of Guanxinning tablets on the coronary microcirculation after PPCI in STEMI patients. It will offer new ideas for the long - term clinical treatment of STEMI patients after PPCI, and provide important theoretical support for expanding the clinical indications of Guanxinning tablets and exploring the reasons for its improvement of cardiovascular outcomes.

Study Overview

• Status: Not yet recruiting
• Conditions: STEMI; STEMI - ST Elevation Myocardial Infarction; Coronary Microvascular Dysfunction (CMD); CMD; STEMI (ST Elevation MI)
• Intervention / Treatment: Drug: Guanxinning Tablet(GXNT); Drug: Placebo

Detailed Description

This study is a preliminary pre-trial for a single-center, prospective, randomized, double-blind, placebo-controlled trial. The objective is to explore the effect of Guanxinning Tablet on improving coronary microcirculation. A total of 70 STEMI patients who have successfully undergone primary percutaneous coronary intervention (PPCI) will be enrolled. Regardless of whether elective complete revascularization is needed, after the IRA (infarct-related artery) is treated during PPCI, patients will be randomly assigned in a 1:1 ratio to two groups: one group will receive an immediate loading dose of 4 Guanxinning Tablets post-PPCI, followed by a maintenance dose of 4 tablets three times daily (TID) (intervention group), while the other group will receive placebo treatment (placebo group). Both groups will receive standard secondary prevention treatment for coronary heart disease. Patients in both groups will undergo cardiac magnetic resonance (CMR) examinations within 1 week after PPCI and at 6 months (±14 days) post-PPCI.

Primary Endpoint:

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.

Secondary Endpoints:

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

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

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

      • Change in myocardial infarct size and percentage of myocardial edema volume measured by CMR at 6 months.

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

          • Change in angina pectoris score at 6 months. ⑦ Change in traditional Chinese medicine (TCM) syndrome score for blood stasis pattern at 6 months.

            • Association between changes in circulating inflammatory markers (oxidized LDL, IL-6, hsCRP) and diabetes markers (HbA1c, FBG, GSP) at 6 months with coronary microcirculation status.

Safety Endpoints:

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 18 and 80 years (gender is not restricted).
• STEMI diagnosed for the first time and with an onset time within 12 hours. (According to the "Chinese Guidelines for the Diagnosis and Treatment of Acute ST - Segment Elevation Myocardial Infarction 2019" and the fourth - edition "Global Definition of Myocardial Infarction" criteria, myocardial infarction refers to acute myocardial injury [serum cardiac troponin (cTn) increases and/or decreases, and at least once is higher than the upper limit of the normal value (the 99th percentile of the upper limit of the reference value)], along with clinical evidence of acute myocardial ischemia, including: (1) Symptoms of acute myocardial ischemia; (2) New ischemic electrocardiogram changes; (3) New pathological Q - wave; (4) New imaging evidence of viable myocardial loss or abnormal wall segmental motion; (5) Coronary artery thrombosis confirmed by coronary angiography, intracavitary imaging examination, or autopsy.)
• Successfully received PPCI treatment (assessed by visual inspection or quantitative coronary angiography, with residual stenosis of the target lesion < 20% after stent implantation or < 50% after simple balloon dilation, and forward TIMI blood flow ≥ grade 2).
• Signed a written informed consent form.

Exclusion Criteria:

• Cardiogenic shock with poor response to vasoactive drugs; or uncontrolled acute left - heart failure or pulmonary edema; uncontrolled malignant arrhythmia.
• LVEF < 40%.
• Currently using nicorandil, other Chinese patent medicines, and Chinese herbal decoctions, etc.
• Unable to undergo CMR examination for various reasons.
• Expected to be unable to complete 6 - month treatment with Guanxinning Tablets.
• Contraindications or allergies to Guanxinning Tablets.
• Suspected or confirmed hereditary cardiomyopathy (such as hypertrophic, dilated, obstructive cardiomyopathy, cardiac amyloidosis, hemochromatosis cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, etc.).
• Active or chronic liver disease.
• Renal insufficiency (eGFR < 60ml/min/1.73m²).
• History of previous cerebral hemorrhage.
• History of alcohol or drug abuse.
• Known active infection, or severe hematological, metabolic, or endocrine dysfunction.
• Patients who have received systemic steroid or cyclosporine treatment in the past 3 months.
• Active malignant tumor.
• Life expectancy less than 6 months.
• Pregnant or lactating women.
• Already participating in other clinical studies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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
Placebo Comparator: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
△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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of IMH (%)	Change in the incidence of IMH in the IRA-supplied myocardial territory measured by CMR at 6 months.	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.	6 months
incidence of MVO (%)	Change in the incidence of MVO in the IRA-supplied myocardial territory measured by CMR at 6 months.	6 months
myocardial infarct size (/ventricular volume, %)	Change in myocardial infarct size (/ventricular volume,%) measured by CMR at 6 months.	6 months
myocardial edema volume (/ventricular volume, %)	Change in percentage of myocardial edema volume (/ventricular volume, %) measured by CMR at 6 months.	6 months
△LVEF (%)	Change in left ventricular ejection fraction (LVEF) measured by echocardiography at 6 months.	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.	6 months
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.	6 months
circulating inflammatory markers absolute change(oxidized LDL, mmol/L)	absolute changes in circulating inflammatory markers: oxidized LDL(mmol/L) at 6 months	6 months
circulating inflammatory markers absolute change (IL-6, pg/mL)	absolute changes in circulating inflammatory markers: IL-6(pg/mL) at 6 months	6 months
circulating inflammatory markers absolute change (hsCRP, mg/L)	absolute changes in circulating inflammatory markers hsCRP(mg/L) at 6 months	6 months
diabetes markers absolute change (HbA1c, %)	absolute changes in diabetes markers: HbA1c(%) at 6 months	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	6 months
diabetes markers absolute change of GSP, Glycated serum protein (%)	absolute changes in diabetes markers: GSP, Glycated serum protein (%) at 6 months	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: May 18, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: CMR; traditional chinese medicine; TCM; intramyocardial hemorrhage; guanxinning tablet
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Myocardial Infarction; Ischemia; Pathological Conditions, Signs and Symptoms; ST Elevation Myocardial Infarction
• Other Study ID Numbers: GXN-CIRC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No