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

NCT07621107 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: GXN-CIRC
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

STEMI (ST Elevation MI); STEMI - ST Elevation Myocardial Infarction; STEMI; CMD; Coronary Microvascular Dysfunction (CMD)

Keywords

TCM; traditional chinese medicine; guanxinning tablet; CMR; intramyocardial hemorrhage

Outcome Measures

Primary Outcomes (1)

• △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 Outcomes (14)

• incidence of IMH (%)

  6 months

• △MVO volume (%)

  6 months

• incidence of MVO (%)

  6 months

• myocardial infarct size (/ventricular volume, %)

  6 months

• myocardial edema volume (/ventricular volume, %)

  6 months

Other Outcomes (1)

• Safety Outcomes

  6 months

Study Arms (2)

GXNT treatment group

EXPERIMENTAL

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)

standard treatment group

PLACEBO COMPARATOR

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

Interventions

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

GXNT treatment group

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.

standard treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: June 2, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 2, 2026

Record last verified: 2026-05