Clinical trial NCT06342141: Empagliflozin for No-reflow Phenomenon in PCI for STEMI
Official title: Empagliflozin for Reducing the Risk of No-Reflow Phenomenon in Patients Undergoing Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: STEMI
No-Reflow Phenomenon
Lead sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Non-Reflow Phenomenon
timeFrame: During percutaneous coronary intervention (approximately 60 minutes after receiving the loading dose)
Secondary outcomes:
measure: Infract size
timeFrame: 72 hours after the loading dose
measure: Longitudinal Strain
timeFrame: 24 hours after the loading dose
measure: High-sensitivity Troponin Clearance
timeFrame: 72 hours after the loading dose
measure: Creatine Kinase-myocardial band Clearance
timeFrame: 72 hours after the loading dose
measure: Adverse Cardiovascular Events
timeFrame: Up to 3 months after the loading dose
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: National Institute of Cardiology
Study officials:
affiliation: Deputy Head of the Department of Interventional Cardiology at the National Institute of Cardiology
name: Eduardo Arias-Sanchez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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