NCT06187727

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
248

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2023

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 3, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

December 2, 2025

Status Verified

November 1, 2023

Enrollment Period

1.5 years

First QC Date

December 17, 2023

Last Update Submit

November 25, 2025

Conditions

Myocardial InfarctionHeart Failure

Keywords

myocardial infartctionVentricular remodeling

Outcome Measures

Primary Outcomes (1)

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

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

    3 days after the primary PCI

Secondary Outcomes (5)

  • Left ventricular remodeling

    6 months after primary PCI

  • contrast induced by nephropathy

    5 days after the primary PCI

  • Cardiovascular adverse events

    12 months after primary PCI

  • renal function renal function Renal function

    6 months after primary PCI

  • Infarct size

    7 days after the primary PCI

Study Arms (2)

henagliflozein group

EXPERIMENTAL

Patients in henagliflozein group was given henagliflozein once a day for 6 months after myocardial infarction.

Drug: Henagliflozin

Placebo group

NO INTERVENTION

Patients in placebo group was given palcebo once a day for 6 months after myocardial infarction.

Interventions

HenagliflozinDRUG

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

henagliflozein group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA general hospital

Beijing, Beijing Municipality, 100853, China

Location

Related Publications (5)

  • Lee TM, Chang NC, Lin SZ. Dapagliflozin, a selective SGLT2 Inhibitor, attenuated cardiac fibrosis by regulating the macrophage polarization via STAT3 signaling in infarcted rat hearts. Free Radic Biol Med. 2017 Mar;104:298-310. doi: 10.1016/j.freeradbiomed.2017.01.035. Epub 2017 Jan 26.

    PMID: 28132924RESULT

  • Tanajak P, Sa-Nguanmoo P, Sivasinprasasn S, Thummasorn S, Siri-Angkul N, Chattipakorn SC, Chattipakorn N. Cardioprotection of dapagliflozin and vildagliptin in rats with cardiac ischemia-reperfusion injury. J Endocrinol. 2018 Feb;236(2):69-84. doi: 10.1530/JOE-17-0457. Epub 2017 Nov 15.

    PMID: 29142025RESULT

  • Mizuno M, Kuno A, Yano T, Miki T, Oshima H, Sato T, Nakata K, Kimura Y, Tanno M, Miura T. Empagliflozin normalizes the size and number of mitochondria and prevents reduction in mitochondrial size after myocardial infarction in diabetic hearts. Physiol Rep. 2018 Jun;6(12):e13741. doi: 10.14814/phy2.13741.

    PMID: 29932506RESULT

  • Andreadou I, Efentakis P, Balafas E, Togliatto G, Davos CH, Varela A, Dimitriou CA, Nikolaou PE, Maratou E, Lambadiari V, Ikonomidis I, Kostomitsopoulos N, Brizzi MF, Dimitriadis G, Iliodromitis EK. Empagliflozin Limits Myocardial Infarction in Vivo and Cell Death in Vitro: Role of STAT3, Mitochondria, and Redox Aspects. Front Physiol. 2017 Dec 19;8:1077. doi: 10.3389/fphys.2017.01077. eCollection 2017.

    PMID: 29311992RESULT

  • Stone GW, Selker HP, Thiele H, Patel MR, Udelson JE, Ohman EM, Maehara A, Eitel I, Granger CB, Jenkins PL, Nichols M, Ben-Yehuda O. Relationship Between Infarct Size and Outcomes Following Primary PCI: Patient-Level Analysis From 10 Randomized Trials. J Am Coll Cardiol. 2016 Apr 12;67(14):1674-83. doi: 10.1016/j.jacc.2016.01.069.

    PMID: 27056772RESULT

MeSH Terms

Conditions

Myocardial InfarctionHeart FailureVentricular Remodeling

Interventions

henagliflozin

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisPathological Conditions, Anatomical

Study Officials

  • Nan Bai, MD

    Chinese PLA General Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 17, 2023

First Posted

January 3, 2024

Study Start

July 1, 2023

Primary Completion

January 1, 2025

Study Completion

October 1, 2025

Last Updated

December 2, 2025

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)