Not Yet RecruitingPhase 2

Timing of Empagliflozin in Primary PCI: Pre-Reperfusion Versus Post-Reperfusion Versus Placebo in South Asian STEMI Patients

Pakistan480 participantsStarted 2026-09-01

Plain-language summary

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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. * Scheduled for primary PCI with intent to perform balloon inflation and stenting. * eGFR ≥45 mL/min/1.73m² (CKD-EPI) from point-of-care creatinine at presentation. * Able to take oral medication (or crushed tablet with water), swallowing ability confirmed by treating nurse. * Written informed consent from patient or legally authorised representative Exclusion Criteria: * 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. * eGFR \<45 mL/min/1.73m² at presentation. * Severe hepatic impairment (Child-Pugh Class C). * Known hypersensitivity to empagliflozin or any SGLT2 inhibitor. * History of diabetic ketoacidosis (euglycaemic or classical) at any time. * Pregnancy, breastfeeding, or refusal of contraception (women of childbearing potential). * Prior myocardial infarction or prior coronary revascularisation. * Left main culprit artery as the infarct-related vessel. * Rescue PCI after fibrinolysis in the curren…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Log-Transformed High-Sensitivity Troponin-I Area Under the Curve (AUC) Over 0-48 Hours Post-Reperfusion

Timeframe: 0-48 hours after successful reperfusion by primary PCI

Trial details

NCT IDNCT07749014

SponsorRehman Medical Institute - RMI

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-30

Contact for this trial

Syed M Rayyan, MBBS

+923369949269 drsmuhammadrayyan@gmail.com

View on ClinicalTrials.gov More ST-elevation Myocardial Infarction (STEMI) trials