Empagliflozin for No-reflow Phenomenon in PCI for STEMI (EMPA-PCI)

April 13, 2026 updated by: Instituto Nacional de Cardiologia Ignacio Chavez

Empagliflozin for Reducing the Risk of No-Reflow Phenomenon in Patients Undergoing Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction

Myocardial infarction remains, in our current era, a leading cause of morbidity and mortality both domestically and globally. A significant contributor to this issue is reperfusion injury, which enlarges the infarction, deteriorates ventricular function, leads to poorer outcomes, and currently has no specific treatment. Originally developed as an antidiabetic, empagliflozin has shown significant benefits in other organs and systems. Recent years have seen the demonstration of its cellular and vascular effects in animal models, potentially contributing to the reduction of reperfusion damage. However, no human studies have yet confirmed these effects.

Consequently, this randomized, parallel-arm clinical trial was designed to evaluate the effect of empagliflozin treatment, administered from the pre-intervention period through to 3 days post-intervention, on the incidence of the no-reflow phenomenon in patients with ST-segment elevation myocardial infarction (STEMI) undergoing coronary angioplasty compared to a placebo.

Before entering the hemodynamics room, participants in the intervention group will receive a loading dose of 25 mg of empagliflozin or a standar treatment. In-hospital treatment will continue with 10 mg empagliflozin daily for 3 days for the intervention group. Patients will be monitored weekly during the first month and bi-weekly during the second and third months.

The primary outcome will be the incidence of the no-reflow phenomenon, measured through the Thrombolysis in Myocardial infarction (TIMI) flow scale in the coronary angiography performed to treat the infarction. Secondary outcomes will include the reduction of ST segment on the electrocardiogram, troponin levels, differences in the longitudinal strain by echocardiogram, and infarct size by magnetic resonance imaging.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

162

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Mexico City
      • Mexico City, Mexico City, Mexico, 14080
        • National Institute of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Acute myocardial infarction with ST-segment elevation
  • Presentation to the institute within 12 hours of symptom onset
  • Coronary angioplasty chosen as the reperfusion treatment for the subject
  • Known diagnosis of diabetes or admission glucose >180 mg/dl.
  • Informed consent signed

Exclusion Criteria:

  • Hemodynamically unstable subjects
  • Subjects undergoing thrombolysis treatment in the current event
  • History of coronary revascularization surgery
  • Known allergy or hypersensitivity to Sodium-glucose co-transporter-2 (SGLT2) inhibitors
  • History of recurrent urinary tract infections
  • Known chronic kidney disease and estimated glomerular filtration rate (eGFR) < 20
  • Ongoing treatment with any SGLT2 inhibitor
  • Participation in another clinical trial or having participated in the week prior to recruitment
  • For women of childbearing age: Current or planned pregnancy or lactation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Empagliflozin
The patients included in this group will receive a loading dose of 25 mg of Empagliflozin at the time of enrollment in the study, prior to percutaneous coronary intervention. Over the following three days, they will receive a daily maintenance dose of 10 mg of Empagliflozin.
Drug: Empagliflozin 25 milgrams (Mg)
Load dose
Other Names:
  • Jardiance 25 Mg
Drug: Empagliflozin 10 Mg
Maintenance dose
Other Names:
  • Jardiance 10 Mg
No Intervention: Standar Treatment
The patients included in this group will receive standar treatment according to the current guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-Reflow Phenomenon
Time Frame: During percutaneous coronary intervention (approximately 60 minutes after receiving the loading dose)

Incidence of non-reflow phenomenon during percutaneous coronary intervention measured using the Thrombolysis in myocardial infarction (TIMI) Flow Grading System. Dichotomous variable (yes/no).

The TIMI flow grading system ranges from 0 to 3. Grade 3 flow is the best result of angioplasty and means that flow has been restored to normal. Grade 2 flow means that the contrast flows throughout the entire artery but more slowly than normal. Grade 1 flow means that the contrast flows through the artery but does not reach the end of the artery. Flow grade 0 means that contrast does not flow in the artery. It is the worst result of an angiography. Any flow other than grade 3 is interpreted as a non-reflow phenomenon.
During percutaneous coronary intervention (approximately 60 minutes after receiving the loading dose)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infract size
Time Frame: 72 hours after the loading dose
Myocardial infarct size measured in grams using cardiac magnetic resonance. Continuous variable. Mean difference between both groups. This outcome will not be combined with other secondary outcomes.
72 hours after the loading dose
Longitudinal Strain
Time Frame: 24 hours after the loading dose
Longitudinal Strain measured in percentage using transthoracic echocardiogram. Continuous variable. Mean difference between both groups. This outcome will not be combined with other secondary outcomes.
24 hours after the loading dose
High-sensitivity Troponin Clearance
Time Frame: 72 hours after the loading dose
Percentage of High-sensitivity troponin decrease when comparing admission values with values at 72 hours. Continuous variable. Mean difference between both groups. This outcome will not be combined with other secondary outcomes.
72 hours after the loading dose
Creatine Kinase-myocardial band Clearance
Time Frame: 72 hours after the loading dose
Percentage of creatine kinase-myocardial band (CK-MB) decrease when comparing admission values with values at 72 hours. Continuous variable. Mean difference between both groups. This outcome will not be combined with other secondary outcomes.
72 hours after the loading dose
Adverse Cardiovascular Events
Time Frame: Up to 3 months after the loading dose
Incidence of Rehospitalization, malignant arrhythmias, cardiogenic shock, reinfarction, urgent revascularization, death. This outcome will not be combined with other secondary outcomes.
Up to 3 months after the loading dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cardiologia Ignacio Chavez

Investigators

  • Principal Investigator: Eduardo Arias-Sanchez, MD, Deputy Head of the Department of Interventional Cardiology at the National Institute of Cardiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2024

Primary Completion (Actual)

March 15, 2026

Study Completion (Estimated)

June 15, 2026

Study Registration Dates

First Submitted

March 11, 2024

First Submitted That Met QC Criteria

March 28, 2024

First Posted (Actual)

April 2, 2024

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-1423

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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