Empagliflozin for No-reflow Phenomenon in PCI for STEMI

Sponsor
Instituto Nacional de Cardiologia Ignacio Chavez
Study ID
NCT06342141
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • No-Reflow Phenomenon
  • STEMI

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Aug 22, 2024
Status verified
Apr 2026
Primary completion
Mar 15, 2026
Completion
Jun 15, 2026

Study Design

Enrollment
162 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.
  • No Intervention: Standar Treatment
    The patients included in this group will receive standar treatment according to the current guidelines

Primary Outcome Measure

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

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