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A randomized controlled clinical trial plan of Guanxingning tablets in intervention of postoperative pump failure in STEMI patients after PCI

A randomized controlled clinical trial plan of Guanxingning tablets in intervention of postoperative pump failure in STEMI patients after PCI

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000619
Enrollment
Unknown
Registered
2025-03-31
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pump failure after primary percutaneous coronary intervention (PCI) for acute ST-segment elevation myocardial infarction

Interventions

experimental group:Conventional Western Medicine and Guanxinning Tablets treatment
control group:Conventional Western Medicine and Placebo treatment

Sponsors

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Meet the diagnostic criteria of STEMI and is in the acute phase (within 4 weeks of onset);2)Successful PCI with reperfusion therapy;3)Echocardiography:LVEF=50%;4)Killip classification: class II-III;5)Age range : 18-80 years old.

Exclusion criteria

Exclusion criteria: 1) Those who have taken experimental drugs other traditional Chinese medicines or traditional Chinese patent medicines within the last month;2) Those who are known to have adverse reactions to the investigational drugs;3) Those who are known to be allergic to the investigational drugs;4) Severe liver dysfunction (ALT>100U/L or AST>100U/L);5) Severe renal insufficiency (glomerular filtration rate<30ml/min);6) Hematological disorders and malignant tumors;7) Pregnancy or lactation period;8) Psychiatric patients;9) Uncontrollable hypertension or diabetes.

Design outcomes

Primary

MeasureTime frame
Left ventricular ejection fraction (LVEF Simpson's method);

Secondary

MeasureTime frame
NT-proBNP;Echocardiographic indices (LVEDD LVESD IVS LVPW FS E/e' E/A etc.);Twelve-lead electrocardiogram;electrolyte examination;Liver and kideny function;Routine urine tests;Minnesota Heart Failure Quality of Life Scale;6-minute walk test;Routine stool examination;Coagulation function;Macro-Micro Indicators in the Four-Dimensional Triangular Framework of Heart Failure;Chinese Medicine Symptoms and Signs;routine blood test;Adverse cardiovascular events;TCM symptoms and vital signs;

Countries

China

Contacts

Public ContactZhao Xinjun

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

zxjhwxm@sina.com15625078269

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026