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NCT Number: NCT07621107

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.

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Key information

Conditions

STEMI (ST Elevation MI) CMD Cardiovascular Diseases Coronary Microvascular Dysfunction (CMD) Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction STEMI STEMI - ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Guanxinning Tablet(GXNT)

Drug

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

Drug

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.

Primary outcomes

  1. △IMH volume (%)

    Time frame: 6 months

    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 outcomes

  1. incidence of IMH (%)

    Time frame: 6 months

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

  2. △MVO volume (%)

    Time frame: 6 months

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

  3. incidence of MVO (%)

    Time frame: 6 months

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

  4. myocardial infarct size (/ventricular volume, %)

    Time frame: 6 months

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

  5. myocardial edema volume (/ventricular volume, %)

    Time frame: 6 months

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

  6. △LVEF (%)

    Time frame: 6 months

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

  7. CCS Angina Classification change

    Time frame: 6 months

    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.

  8. TCM blood stasis pattern score change

    Time frame: 6 months

    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.

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

    Time frame: 6 months

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

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

    Time frame: 6 months

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

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

    Time frame: 6 months

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

  12. diabetes markers absolute change (HbA1c, %)

    Time frame: 6 months

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

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

    Time frame: 6 months

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

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

    Time frame: 6 months

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

Other outcomes

  1. Safety Outcomes

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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