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

November 25, 2025 updated by: Qian geng

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

248

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100853
        • Chinese PLA General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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;
  2. Chest pain lasting less than 12 hours;
  3. Age range from 18 to 80 years old;
  4. Plans to undergo primary PCI ;
  5. Informed consent form

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: henagliflozein group
Patients in henagliflozein group was given henagliflozein once a day for 6 months after myocardial infarction.
Drug: Henagliflozin
After primary PCI, Henggliflozin or Placebo was administered within 24 hours, followed by daily oral administration until 6 months post-acute myocardial infarction.
No Intervention: Placebo group
Patients in placebo group was given palcebo once a day for 6 months after myocardial infarction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 days after the primary PCI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months after primary PCI
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.
5 days after the primary PCI
Cardiovascular adverse events
Time Frame: 12 months after primary PCI
readmission due to heart failure, daeath, myocardial infarction
12 months after primary PCI
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
6 months after primary PCI
Infarct size
Time Frame: 7 days after the primary PCI
Infarct size measured by cardiac magnetic resonance imaging
7 days after the primary PCI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qian geng

Investigators

  • Study Director: Nan Bai, MD, Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Actual)

January 1, 2025

Study Completion (Actual)

October 1, 2025

Study Registration Dates

First Submitted

December 17, 2023

First Submitted That Met QC Criteria

December 17, 2023

First Posted (Actual)

January 3, 2024

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Henagliflozin for infarction
  • Z-2017-26-2202-04 (Other Grant/Funding Number: China International Medical Fundinging)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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