A Phase 4 interventional study of Henagliflozin in Myocardial Infarction and Heart Failure, sponsored by Qian geng. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Qian geng · Phase 4, Interventional, and Treatment
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.
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).
2,270 studies on the registry are indexed under Myocardial Infarction; 371 are open to participants now.
This study's enrollment of 248 is above the median of 150 across 1,314 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Qian geng is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in henagliflozein group was given henagliflozein once a day for 6 months after myocardial infarction.
Drug: Henagliflozin
Patients in placebo group was given palcebo once a day for 6 months after myocardial infarction.
After primary PCI, Henggliflozin or Placebo was administered within 24 hours, followed by daily oral administration until 6 months post-acute myocardial infarction.
Area under the curve of myocardial enzymes (CK-MB)
Postoperative dynamic monitoring of myocardial enzyme （CK-MB）changes post infarction
Time frame: 3 days after the primary PCI
Left ventricular remodeling
Left ventricular remodeling evaluated by echocardiography，left ventricular end diastolic volume increase more than 20% compared bybaseline
Time frame: 6 months after primary PCI
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.
Time frame: 5 days after the primary PCI
Cardiovascular adverse events
readmission due to heart failure, daeath, myocardial infarction
Time frame: 12 months after primary PCI
renal function renal function Renal function
Glomerular filtration rate evaluated glomerular filtration rate 6 months after primary PCI
Time frame: 6 months after primary PCI
Infarct size
Infarct size measured by cardiac magnetic resonance imaging
Time frame: 7 days after the primary PCI
Plan to share: No
Ran from Jul 2023 to primary completion in Jan 2025, 18 months.
Of 83 non-industry phase 4 interventional studies under Myocardial Infarction, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 78. This study's 18 months is below that.
Counting every sponsor, half of 87 studies reached it within 42 months; a quarter within 22 and three quarters within 78.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Henagliflozin
Qian geng