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NCT Number: NCT06187727

Henagliflozin Reducing Infarct Size After Priamry PCI in Patients With ST Segment Elevation Myocardial Infarction

This Randomized controlled intervention study recruited patients diagnosed with ST-segment elevation myocardial infarction (STEMI). A total of 240 patients were enrolled in either Henagliflozin group or control group. Patients in Henggliflozin group will be given by oral administration of Henggliflozin for 6 months post acute myocardial infarction. Prior to procedure, dynamic changes in myocardial enzymes were monitored. Major cardiovascular events, including non-fatal myocardial infarction, all-cause death, revascularization due to angina, and hospitalization for acute heart failure. This study aims to assess the impact of Henggelizin intervention on the reduction of myocardial infarction size (evaluated by cardiac enzyme) and improvement of left ventricular remodeling in patients with ST-segment elevation myocardial infarction.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chinese PLA general hospital

Beijing, Beijing Municipality, 100853, China

About this study

This Randomized controlled intervention study recruited patients diagnosed with ST-segment elevation myocardial infarction (STEMI) who were scheduled to undergo emergency percutaneous coronary intervention (PCI) . A total of 240 patients were selected for both the Henagliflozin group and control group. In the emergency room, clinical data would be collected, along with peripheral venous blood samples for laboratory examination. This examination should include blood routine analysis, myocardial enzyme, blood glucose levels, liver and kidney function, and brain natriuretic peptide precursor (NT proBNP) measurement. After primary PCI, Henggliflozin was administered, followed by daily oral administration of one tablet until 6 months post-acute myocardial infarction. Prior to procedure, dynamic changes in myocardial enzymes and electrocardiogram were monitored, with subsequent monitoring at 6 hours, 24 hours, and 48 hours after myocardial infarction. Perioperative complications were documented, followed by cardiac ultrasound assessments of myocardial wall motion and cardiac structure at seven days post primary PCI and six months post procedure. Major cardiovascular events, including non-fatal myocardial infarction, all-cause death, revascularization due to angina, and hospitalization for acute heart failure, were observed through follow-up at 1 month, 2 months, 3 months, and 6 months after PCI. This study aims to assess the impact of postoperative Henggelizin intervention on the reduction of myocardial infarction size and improvement of left ventricular remodeling in patients with ST-segment elevation myocardial infarction (STEMI).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • STEMI patients with clear diagnosis: ischemic chest pain lasting for more than 30 minutes and adjacent to two or more leads of ST Segment elevation (limb lead ≥ 0.1mV, chest lead ≥ 0.2mV) with or without elevated myocardial enzyme levels;
  • Chest pain lasting less than 12 hours;
  • Age range from 18 to 80 years old;
  • Plans to undergo primary PCI ;
  • Informed consent form

Exclusion criteria

  • Mechanical complications;
  • Cardiogenic shock;
  • Experienced myocardial infarction within 6 months;
  • Aortic dissection;
  • Suffering from malignant tumors, severe liver and kidney failure, respiratory failure, or other short-term progressive diseases that researchers believe cannot be included
  • Urinary system infection

Treatment and study plan

Henagliflozin

Drug

After primary PCI, Henggliflozin or Placebo was administered within 24 hours, followed by daily oral administration until 6 months post-acute myocardial infarction.

Primary outcomes

  1. Area under the curve of myocardial enzymes (CK-MB)

    Time frame: 3 days after the primary PCI

    Postoperative dynamic monitoring of myocardial enzyme (CK-MB)changes post infarction

Secondary outcomes

  1. Left ventricular remodeling

    Time frame: 6 months after primary PCI

    Left ventricular remodeling evaluated by echocardiography,left ventricular end diastolic volume increase more than 20% compared bybaseline

  2. contrast induced by nephropathy

    Time frame: 5 days after the primary PCI

    absolute increase in serum creatinine (SCr) 48-72 hours after primary PCI > 0.5 mg/dl or a relative increase > 25% compared with baseline SCr.

  3. Cardiovascular adverse events

    Time frame: 12 months after primary PCI

    readmission due to heart failure, daeath, myocardial infarction

  4. renal function renal function Renal function

    Time frame: 6 months after primary PCI

    Glomerular filtration rate evaluated glomerular filtration rate 6 months after primary PCI

  5. Infarct size

    Time frame: 7 days after the primary PCI

    Infarct size measured by cardiac magnetic resonance imaging

Sponsors and collaborators

Lead sponsor

Qian geng

Other

Registry information

Official study title

Clinical Study on Reducing Myocardial Infarction Siez After Primary PCI in Patients With ST Segment Elevation Myocardial Infarction by Using Henagliflozin

Acronym: Health

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 3, 2024
Registry last updated
Dec 2, 2025

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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