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STEMIPhase 2EMPA-PCINCT06342141

Empagliflozin for No-reflow Phenomenon in PCI for STEMI

A Phase 2 study testing Empagliflozin 25 milgrams (Mg) and Empagliflozin 10 Mg in people with STEMI and No-Reflow Phenomenon, run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
STEMI, No-Reflow Phenomenon
What is being tested?
Empagliflozin 25 milgrams (Mg) and Empagliflozin 10 Mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
162 participants
Where
1 siteMexico
Study dates
22 Aug 2024to 15 Jun 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • National Institute of Cardiology

    Mexico City, Mexico City, 14080

Other trials in Mexico

About this study

Official title: 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.

Read more

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.

Being tested
Empagliflozin 25 milgrams (Mg), Empagliflozin 10 Mg
Medical subject headings
ST Elevation Myocardial Infarction, No-Reflow Phenomenon

What participants receive

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

  • Empagliflozin 25 milgrams (Mg)Drug

    Also called Jardiance 25 Mg

    Load dose

  • Empagliflozin 10 MgDrug

    Also called Jardiance 10 Mg

    Maintenance dose

Study groups in NCT06342141
Study groupRoleWhat they receive
EmpagliflozinExperimentalThe 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.
Receives: Drug: Empagliflozin 25 milgrams (Mg); Drug: Empagliflozin 10 Mg
Standar TreatmentNo interventionThe patients included in this group will receive standar treatment according to the current guidelines

What is being measured

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

  1. Non-Reflow Phenomenon

    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.

    Measured: During percutaneous coronary intervention (approximately 60 minutes after receiving the loading dose)

Secondary outcomes (5)

  1. Infract size

    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.

    Measured: 72 hours after the loading dose

  2. Longitudinal Strain

    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.

    Measured: 24 hours after the loading dose

  3. High-sensitivity Troponin Clearance

    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.

    Measured: 72 hours after the loading dose

  4. Creatine Kinase-myocardial band Clearance

    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.

    Measured: 72 hours after the loading dose

  5. Adverse Cardiovascular Events

    Incidence of Rehospitalization, malignant arrhythmias, cardiogenic shock, reinfarction, urgent revascularization, death. This outcome will not be combined with other secondary outcomes.

    Measured: Up to 3 months after the loading dose

Timeline

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

  1. First posted2 Apr 2024
  2. Study start22 Aug 2024
  3. Primary completion15 Mar 2026
  4. Study completion15 Jun 2026 (estimated)

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
162 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06342141
Sponsor's protocol ID
24-1423
Acronym
EMPA-PCI
Status last verified
Apr 2026
First submitted
11 Mar 2024
Last updated
15 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Niccoli G, Kharbanda RK, Crea F, Banning AP. No-reflow: again prevention is better than treatment. Eur Heart J. 2010 Oct;31(20):2449-55. doi: 10.1093/eurheartj/ehq299. Epub 2010 Sep 13. No abstract available.

    PubMed 20837571

  • Tasar O, Karabay AK, Oduncu V, Kirma C. Predictors and outcomes of no-reflow phenomenon in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention. Coron Artery Dis. 2019 Jun;30(4):270-276. doi: 10.1097/MCA.0000000000000726.

    PubMed 31026233

  • Niccoli G, Burzotta F, Galiuto L, Crea F. Myocardial no-reflow in humans. J Am Coll Cardiol. 2009 Jul 21;54(4):281-92. doi: 10.1016/j.jacc.2009.03.054.

    PubMed 19608025

  • Annibali G, Scrocca I, Aranzulla TC, Meliga E, Maiellaro F, Musumeci G. "No-Reflow" Phenomenon: A Contemporary Review. J Clin Med. 2022 Apr 16;11(8):2233. doi: 10.3390/jcm11082233.

    PubMed 35456326

  • Sayour AA, Korkmaz-Icoz S, Loganathan S, Ruppert M, Sayour VN, Olah A, Benke K, Brune M, Benko R, Horvath EM, Karck M, Merkely B, Radovits T, Szabo G. Acute canagliflozin treatment protects against in vivo myocardial ischemia-reperfusion injury in non-diabetic male rats and enhances endothelium-dependent vasorelaxation. J Transl Med. 2019 Apr 16;17(1):127. doi: 10.1186/s12967-019-1881-8.

    PubMed 30992077

  • Cooper S, Teoh H, Campeau MA, Verma S, Leask RL. Empagliflozin restores the integrity of the endothelial glycocalyx in vitro. Mol Cell Biochem. 2019 Sep;459(1-2):121-130. doi: 10.1007/s11010-019-03555-2. Epub 2019 May 24.

    PubMed 31127491

  • Lahnwong C, Palee S, Apaijai N, Sriwichaiin S, Kerdphoo S, Jaiwongkam T, Chattipakorn SC, Chattipakorn N. Acute dapagliflozin administration exerts cardioprotective effects in rats with cardiac ischemia/reperfusion injury. Cardiovasc Diabetol. 2020 Jun 15;19(1):91. doi: 10.1186/s12933-020-01066-9.

    PubMed 32539724

  • Shao Q, Meng L, Lee S, Tse G, Gong M, Zhang Z, Zhao J, Zhao Y, Li G, Liu T. Empagliflozin, a sodium glucose co-transporter-2 inhibitor, alleviates atrial remodeling and improves mitochondrial function in high-fat diet/streptozotocin-induced diabetic rats. Cardiovasc Diabetol. 2019 Nov 28;18(1):165. doi: 10.1186/s12933-019-0964-4.

    PubMed 31779619

  • Kolijn D, Pabel S, Tian Y, Lodi M, Herwig M, Carrizzo A, Zhazykbayeva S, Kovacs A, Fulop GA, Falcao-Pires I, Reusch PH, Linthout SV, Papp Z, van Heerebeek L, Vecchione C, Maier LS, Ciccarelli M, Tschope C, Mugge A, Bagi Z, Sossalla S, Hamdani N. Empagliflozin improves endothelial and cardiomyocyte function in human heart failure with preserved ejection fraction via reduced pro-inflammatory-oxidative pathways and protein kinase Galpha oxidation. Cardiovasc Res. 2021 Jan 21;117(2):495-507. doi: 10.1093/cvr/cvaa123.

    PubMed 32396609

  • Lu Q, Liu J, Li X, Sun X, Zhang J, Ren D, Tong N, Li J. Empagliflozin attenuates ischemia and reperfusion injury through LKB1/AMPK signaling pathway. Mol Cell Endocrinol. 2020 Feb 5;501:110642. doi: 10.1016/j.mce.2019.110642. Epub 2019 Nov 21.

    PubMed 31759100

  • Tan Y, Yu K, Liang L, Liu Y, Song F, Ge Q, Fang X, Yu T, Huang Z, Jiang L, Wang P. Sodium-Glucose Co-Transporter 2 Inhibition With Empagliflozin Improves Cardiac Function After Cardiac Arrest in Rats by Enhancing Mitochondrial Energy Metabolism. Front Pharmacol. 2021 Oct 12;12:758080. doi: 10.3389/fphar.2021.758080. eCollection 2021.

    PubMed 34712142

  • Uthman L, Li X, Baartscheer A, Schumacher CA, Baumgart P, Hermanides J, Preckel B, Hollmann MW, Coronel R, Zuurbier CJ, Weber NC. Empagliflozin reduces oxidative stress through inhibition of the novel inflammation/NHE/[Na+]c/ROS-pathway in human endothelial cells. Biomed Pharmacother. 2022 Feb;146:112515. doi: 10.1016/j.biopha.2021.112515. Epub 2021 Dec 9.

    PubMed 34896968

  • Seo MS, Jung HS, An JR, Kang M, Heo R, Li H, Han ET, Yang SR, Cho EH, Bae YM, Park WS. Empagliflozin dilates the rabbit aorta by activating PKG and voltage-dependent K+ channels. Toxicol Appl Pharmacol. 2020 Sep 15;403:115153. doi: 10.1016/j.taap.2020.115153. Epub 2020 Jul 24.

    PubMed 32717242

  • Zou R, Shi W, Qiu J, Zhou N, Du N, Zhou H, Chen X, Ma L. Empagliflozin attenuates cardiac microvascular ischemia/reperfusion injury through improving mitochondrial homeostasis. Cardiovasc Diabetol. 2022 Jun 15;21(1):106. doi: 10.1186/s12933-022-01532-6.

    PubMed 35705980

  • Solis-Jimenez F, Araiza-Garaygordobil D, Masso-Bueso JS, Villalobos-Ordaz A, Arellano-Juvera F, Arredondo-Aragon F, Melendez-Ramirez G, Valdez-Ortiz R, Alday-Ramirez SM, Rodriguez-Zanella HG, Amezcua Guerra LM, Arias-Mendoza MA, Martinez-Rios MA, Arias-Sanchez EA, Eid-Lidt G. Effect of empagliflozin on reducing the no-reflow phenomenon in patients with ST-elevation myocardial infarction: rationale and design of the EMPA-PCI trial. Eur Heart J Open. 2025 Oct 5;5(6):oeaf128. doi: 10.1093/ehjopen/oeaf128. eCollection 2025 Nov.

    PubMed 41230400

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Empagliflozin 25 milgrams (Mg) and Empagliflozin 10 Mg in people with STEMI and No-Reflow Phenomenon, run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.

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 9 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: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2026. 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 Mexico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Non-Reflow Phenomenon (time frame: During percutaneous coronary intervention (approximately 60 minutes after receiving the loading dose)). 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 NCT06342141, which also lists 15 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 15 Apr 2026.

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