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

Sponsor
Rehman Medical Institute - RMI
Study ID
NCT07749014
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • empagliflozin — DRUG
    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.
  • Placebo — DRUG
    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.

Study Details

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.

Key Dates

First listed
Aug 6, 2026
Start date
Sep 1, 2026
Status verified
Jul 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
480 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pre-reperfusion Empagliflozin
    Participants receive a single empagliflozin 25 mg loading dose immediately after randomization, before cath-lab transfer, with no delay to primary PCI, followed by a matched placebo dose within 2 hours after PCI. Empagliflozin 10 mg once daily is then continued for 90 days, in addition to guideline-directed standard care.
  • Experimental: Post-reperfusion Empagliflozin
    Participants receive a matched placebo dose before primary PCI, followed by a single empagliflozin 25 mg loading dose within 2 hours after successful PCI. Empagliflozin 10 mg once daily is then continued for 90 days, in addition to guideline-directed standard care.
  • Placebo Comparator: Placebo
    Participants receive matched placebo before primary PCI and again within 2 hours after PCI, followed by matched placebo once daily for 90 days, in addition to guideline-directed standard care.

Primary Outcome Measure

Log-Transformed High-Sensitivity Troponin-I Area Under the Curve (AUC) Over 0-48 Hours Post-Reperfusion [ Time Frame: 0-48 hours after successful reperfusion by primary PCI ]

Central Contacts

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