NCT07621107Not yet recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 2 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 18 May 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- Beijing Anzhen Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT07621107
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 70
- From 1 Jun 2026 to the primary completion date, 1 Jan 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently using nicorandil, other Chinese patent medicines, and Chinese herbal decoctions, etc.
- Expected to be unable to complete 6 - month treatment with Guanxinning Tablets.
- History of previous cerebral hemorrhage.
- Patients who have received systemic steroid or cyclosporine treatment in the past 3 months.
Other illness
- Cardiogenic shock with poor response to vasoactive drugs; or uncontrolled acute left - heart failure or pulmonary edema; uncontrolled malignant arrhythmia.
- 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.
- History of alcohol or drug abuse.
- Known active infection, or severe hematological, metabolic, or endocrine dysfunction.
- Active malignant tumor.
Lab values
- LVEF \< 40%.
- Renal insufficiency (eGFR \< 60ml/min/1.73m²).
Other
- Unable to undergo CMR examination for various reasons.
- Life expectancy less than 6 months.
- Pregnant or lactating women.
- Already participating in other clinical studies.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.