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

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.

Conditions

• ST-elevation Myocardial Infarction (STEMI)
• Acute Myocardial Infarction (AMI)
• Coronary Artery Disease

Interventions

DRUG

empagliflozin

Empagliflozin 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.

DRUG

Placebo

Participants 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.

Sponsors & Collaborators

• Michigan State University

  collaborator OTHER

• Rehman Medical Institute - RMI

  lead OTHER

Principal Investigators

• Miqdad A Khan, MD, FACC, FISCI, FSCAI, FACP · Rehman Medical Institute

• Herbert D Aronow, MD, MPH, MSCAI, FACC, MSVM · Michigan State University College of Human Medicine

• Ashraf S Niazi, MBBS, FRCP · Northampton General Hospital, UK

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2027-09-30

Completion

2027-09-30

Countries

• Pakistan

Study Locations