The goal of this clinical trial is to learn if giving the drug empagliflozin before versus after a heart procedure called primary PCI (percutaneous coronary intervention) affects how much heart muscle is damaged during a heart attack. Primary PCI is a procedure that opens blocked heart arteries using a small balloon and stent. While this procedure saves lives, it can also cause extra injury to the heart muscle when blood flow returns. Researchers want to know if empagliflozin given before the procedure can protect the heart better than giving it after the procedure.
The main questions this trial aims to answer are:
Does giving empagliflozin before the PCI procedure reduce heart muscle injury more than a placebo (a look-alike pill with no active drug)?
Does giving empagliflozin before PCI protect the heart better than giving it after PCI?
Does empagliflozin given after PCI reduce heart muscle injury compared with a placebo?
Researchers will compare three groups of participants to see if the timing of empagliflozin matters:
Group A receives empagliflozin before the PCI procedure
Group B receives empagliflozin after the PCI procedure
Group C receives a placebo at both times
All three groups will continue taking their assigned study pills for 90 days.
Participants in this study are adults aged 18 to 75 from South Asian backgrounds (Pakistani, Indian, Bangladeshi, Sri Lankan, or Nepali) who are having their first heart attack and are scheduled for the PCI procedure within 12 hours of their symptoms starting.
Participants will:
Take a single loading dose of the study pill or placebo right before the PCI procedure
Take a single loading dose of the study pill or placebo within 2 hours after the PCI procedure
Continue taking the study pill or placebo once daily for 90 days
Have blood samples taken 6 times over 48 hours to measure heart muscle injury
Have heart function tests at Day 3, Day 30, and Day 90 (echocardiograms, which are ultrasound pictures of the heart)
Have a special heart scan (CMR) between Day 3 and Day 5 for some participants to get detailed pictures of the heart muscle
Complete 90 days of follow-up with clinic visits and tests
Researchers will measure heart muscle injury using a blood test called high-sensitivity troponin. This test measures a protein that is released when heart muscle is damaged. The total amount of this protein released over 48 hours will tell researchers how much heart muscle was injured.
Age 18-75 years at presentation.
South Asian ethnicity (Pakistani, Indian, Bangladeshi, Sri Lankan, or Nepali origin).
First STEMI: ST-elevation ≥1 mm in ≥2 contiguous limb leads, or ≥2 mm in ≥2 contiguous precordial leads, or new LBBB with consistent presentation.
Symptom onset to hospital arrival ≤12 hours.
Cardiogenic shock at presentation (Killip IV: SBP <90 mmHg despite volume, requiring vasopressors, IABP, or mechanical circulatory support).
Type 1 diabetes mellitus.
SGLT2 inhibitor use within 3 months of presentation.
Active urinary tract infection or genital mycotic infection.
Parallel
empagliflozin
DrugEmpagliflozin is an oral sodium-glucose cotransporter-2 (SGLT2) inhibitor administered in addition to guideline-directed medical therapy for acute ST-segment elevation myocardial infarction (STEMI). Participants randomized to the experimental groups receive empagliflozin according to the study protocol. In one experimental arm, empagliflozin is administered before primary percutaneous coronary intervention (PCI) (pre-reperfusion), whereas in the second experimental arm, it is administered immediately after successful reperfusion by primary PCI (post-reperfusion). All subsequent dosing, follow-up, and safety monitoring are conducted according to the protocol.
Placebo
DrugParticipants randomized to the control arm receive matching placebo tablets that are identical in appearance, packaging, and administration schedule to empagliflozin. Placebo is administered in addition to guideline-directed medical therapy to maintain blinding throughout the study. The placebo regimen follows the same schedule as the active intervention without containing the active pharmaceutical ingredient.
Log-Transformed High-Sensitivity Troponin-I Area Under the Curve (AUC) Over 0-48 Hours Post-Reperfusion
The primary outcome is the total myocardial injury burden measured as the log-transformed area under the concentration-time curve (AUC) of high-sensitivity Troponin-I over the first 48 hours following successful reperfusion by primary percutaneous coronary intervention (PCI). Troponin-I concentrations will be measured at 0, 6, 12, 24, and 48 hours post-reperfusion using a single assay platform at a central biomarker core laboratory. The AUC will be calculated using the trapezoidal method and compared between the pre-reperfusion empagliflozin, post-reperfusion empagliflozin, and placebo groups. Time Frame: 0, 6, 12, 24, and 48 hours after successful reperfusion by primary PCI
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Rehman Medical Institute - RMI
Lead sponsor
Michigan State University
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
