Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06342141 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Empagliflozin for No-reflow Phenomenon in PCI for STEMI

Study acronym: EMPA-PCI
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion date changed from estimate of Aug 15, 2025 to Mar 15, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Oct 15, 2025 to Jun 15, 2026
    • Site details revised
    v4
  2. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Jan 15, 2025 to Aug 15, 2025
    • Study sites: 0 to 1
    • Study completion date: Mar 15, 2025 to Oct 15, 2025
    • Start date changed from estimate of Jul 25, 2024 to Aug 22, 2024
  3. Notable Start date: May 15, 2024 to Jul 25, 2024
    • Interventions: Empagliflozin 10 Mg (Drug), Empagliflozin 25 milgrams (Mg) (Drug), Placebo 10 Mg (Drug), Placebo 25 Mg (Drug) to Empagliflozin 10 Mg (Drug), Empagliflozin 25 milgrams (Mg) (Drug)
    • Eligibility criteria expanded, about 9 words
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06342141
Lead Sponsor Instituto Nacional de Cardiologia Ignacio Chavez
Conditions
(from sponsor)
STEMI, No-Reflow Phenomenon
Related terms No-Reflow Phenomenon, ST Elevation Myocardial Infarction
Enrollment 162 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov