The effect of Empagliflozin on outcomes of patients with myocardial infarction undergoing primary PCI

Investigating the effect of Empagliflozin on outcomes of patients with myocardial infarction undergoing primary Percutaneous coronary intervention (PCI):a randomized double-blind clinical trial with placebo

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220809055645N7

Enrollment

Registered

2024-02-17

Start date

2024-03-05

Completion date

Unknown

Last updated

2024-03-06

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

Conditions

ST Elevation myocardial infarction. ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction

Interventions

Intervention 1: Intervention group: Receiving Empagliflozin 10 mg 1 tablet daily. Made by Actover co. Intervention 2: Control group: Receiving Placebo (cellulose micro crystal tablet). 1 tablet daily.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with ST segment elevation myocardial infarction (STEMI) undergoing successful Primary PCI without complications Based on New York Heart Association (NYHA) functional class I,II,III Informed consent for participation in study

Exclusion criteria

Exclusion criteria: Failure of primary PCI Empagliflozin contraindications Valvular heart disease with moderate and higher severity Patients who need hemodynamic support during hospitalization Not willing to continue participation in study Receiving drugs ,eg Non-steroidal anti-inflammatory drugs (NSAIDs) which can not be denied

Design outcomes

Primary

Measure	Time frame
Myocardial reinfarction. Timepoint: During 40-day follow up. Method of measurement: According to symptoms and ECG findings.;Stroke. Timepoint: During 40-day follow up. Method of measurement: According to symptoms and physical examinations.;Cardiac mortality. Timepoint: During 40-day follow up. Method of measurement: Cardiac death according to AHA guideline determined as paroxysmal cardiac arrest with no respiratory and circulatory response.	—

Measure

Time frame

Myocardial reinfarction. Timepoint: During 40-day follow up. Method of measurement: According to symptoms and ECG findings.;Stroke. Timepoint: During 40-day follow up. Method of measurement: According to symptoms and physical examinations.;Cardiac mortality. Timepoint: During 40-day follow up. Method of measurement: Cardiac death according to AHA guideline determined as paroxysmal cardiac arrest with no respiratory and circulatory response.

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Secondary

Measure	Time frame
Ejection fraction. Timepoint: During 40-day follow up. Method of measurement: By echocardiography.;Systolic heart failure. Timepoint: During 40-day follow up. Method of measurement: By echocardiography.;Re admission. Timepoint: During 40-day follow up. Method of measurement: Documented records.;Angina. Timepoint: During 40-day follow up. Method of measurement: History.;Second revascularization. Timepoint: During 40-day follow up. Method of measurement: Based on symptoms ECG and echocardiographic findings.;Empagliflozin complications. Timepoint: During 40-day follow up. Method of measurement: Based on history, symptoms and echocardiography findings.	—

Measure

Time frame

Ejection fraction. Timepoint: During 40-day follow up. Method of measurement: By echocardiography.;Systolic heart failure. Timepoint: During 40-day follow up. Method of measurement: By echocardiography.;Re admission. Timepoint: During 40-day follow up. Method of measurement: Documented records.;Angina. Timepoint: During 40-day follow up. Method of measurement: History.;Second revascularization. Timepoint: During 40-day follow up. Method of measurement: Based on symptoms ECG and echocardiographic findings.;Empagliflozin complications. Timepoint: During 40-day follow up. Method of measurement: Based on history, symptoms and echocardiography findings.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Baharvand

Rasht University of Medical Sciences

dr.baharcardio@gmail.com+98 13 3366 4282

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jul 19, 2026