Skip to content

Empagliflozin on Cardiac-renal Injury in Patients With STEAMI Patients After Primary PCI

Effectiveness of Empagliflozin on Cardiac-renal Injury in Patients With Acute ST-segment-elevation Myocardial Infarction After Primary Percutaneous Coronary Intervention.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03591991
Enrollment
128
Registered
2018-07-19
Start date
2018-10-01
Completion date
2019-09-01
Last updated
2018-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reperfusion Injury, Myocardial

Keywords

Empagliflozin, Percutaneous coronary intervention, Reperfusion Injury, Microvascular protection, CI-AKI, No-Reflow Phenomenon

Brief summary

This study is a single-center, prospective controlled trial addressing effectiveness of empagliflozin on cardiac-renal injury in patients with STEMI. Patients were randomized using a computer-generated sequence to either placebo or empagliflozin at a 1:1 ratio. Investigators, participants, and other study personnel were blinded to the assigned treatment for the duration of the study. The primary objective of this study is to investigate the effects of empagliflozin on myocardial infarct size measured using cardiac magnetic resonance (CMR) methods at 3 months. Key secondary endpoint: incidence of CIAKI within 48h after PCI. Inclusion Criteria:Patients with STEMI who were admitted to the Chinese PLA General Hospital were recruited between Ocotor 2018 and January 2019. STEMI was defined as typical chest pain lasting \>30 minutes within the previous 12 hours, a clear ST-segment elevation of \>0.1 mV in two or more contiguous electrocardiographic leads, and elevated blood levels of troponin T.Exclusion Criteria:Cardiogenic shock ,Hypoglycaemia ,Diabetic ketoacidosis,Genital and urinary infections,History of myocardial infarction,Stent thrombosis,Previous coronary artery bypass surgery,Type 1 Diabetes,Severe hepatic insufficiency,Advanced cancer patients,eGFR\<30 ml/min. All patients were informed of the potential risks (genital mycotic infections, urinary tract infections, diabetic ketoacidosis) associated with empagliflozin and then required to submit written informed consent before being included in the study. Patients were randomized using a computer-generated sequence to either placebo or empagliflozin at a 1:1 ratio. Patients in the empagliflozin group were treated with empagliflozin whereas patients in the control group were given placebo. The treatment started 30 minutes before PCI with a dose of 10 mg empagliflozin or placebo administered in the ambulance. After admission, patients were treated with 10 mg empagliflozin once daily for 3 mouths.

Interventions

DRUGEmpagliflozin

After randomization,the treatment started 30 minutes before PCI with a dose of 10 mg empagliflozin . After admission, patients were treated with 10 mg empagliflozin once daily for 3 mouths.

OTHERplacebo

After randomization,the treatment started 30 minutes before PCI with a dose of 10 mg placebo . After admission, patients were treated with 10 mg placebo once daily for 3 mouths.

Sponsors

Chinese PLA General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with STEMI who were admitted to the Chinese PLA General Hospital were recruited between June 2018 and September 2018.

Exclusion criteria

* Cardiogenic shock * Hypoglycaemia * Diabetic ketoacidosis * Genital and urinary infections * History of myocardial infarction * Stent thrombosis * Previous coronary artery bypass surgery * Type 1 Diabetes * Severe hepatic insufficiency * Advanced cancer patients * eGFR\<30 ml/min

Design outcomes

Primary

MeasureTime frameDescription
final infarct size3 months after PCIthe final infarct size measured by Cardiac magnetic resonance

Secondary

MeasureTime frameDescription
contrast induced acute kidney injury (CIAKI)within 48 hours after PCIincidence of CIAKI within 48 hours after PCI

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026