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Myocardial InfarctionPhase 4HealthNCT06187727

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

A Phase 4 study testing Henagliflozin in people with Myocardial Infarction and Heart Failure, run by Qian geng at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Myocardial Infarction, Heart Failure
What is being tested?
Henagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
248 participants
Where
1 siteChina
Study dates
1 Jul 2023to 1 Oct 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Chinese PLA general hospital

    Beijing, Beijing Municipality, 100853

Other trials in China

About this study

Official title: 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.

Read the 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).

Being tested
Henagliflozin
Keywords
myocardial infartction, Ventricular remodeling
Medical subject headings
Myocardial Infarction, Heart Failure, Ventricular Remodeling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HenagliflozinDrug

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

Study groups in NCT06187727
Study groupRoleWhat they receive
henagliflozein groupExperimentalPatients in henagliflozein group was given henagliflozein once a day for 6 months after myocardial infarction.
Receives: Drug: Henagliflozin
Placebo groupNo interventionPatients in placebo group was given palcebo once a day for 6 months after myocardial infarction.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 3 days after the primary PCI

Secondary outcomes (5)

  1. Left ventricular remodeling

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

    Measured: 6 months after primary PCI

  2. contrast induced by nephropathy

    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.

    Measured: 5 days after the primary PCI

  3. Cardiovascular adverse events

    readmission due to heart failure, daeath, myocardial infarction

    Measured: 12 months after primary PCI

  4. renal function renal function Renal function

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

    Measured: 6 months after primary PCI

  5. Infarct size

    Infarct size measured by cardiac magnetic resonance imaging

    Measured: 7 days after the primary PCI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2024
  2. Study start1 Jul 2023
  3. Primary completion1 Jan 2025
  4. Study completion1 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
248 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06187727
Sponsor's protocol ID
Henagliflozin for infarction
Other IDs
Z-2017-26-2202-04
Acronym
Health
Status last verified
Nov 2023
First submitted
17 Dec 2023
Last updated
2 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28132924

  • 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.

    PubMed 29142025

  • 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.

    PubMed 29932506

  • 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.

    PubMed 29311992

  • 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.

    PubMed 27056772

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Henagliflozin in people with Myocardial Infarction and Heart Failure, run by Qian geng at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the curve of myocardial enzymes (CK-MB) (time frame: 3 days after the primary PCI). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06187727, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.

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