A Phase 2 interventional study of empagliflozin and Placebo in ST-elevation Myocardial Infarction (STEMI), Acute Myocardial Infarction (AMI) and Coronary Artery Disease, sponsored by Rehman Medical Institute - RMI. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Rehman Medical Institute - RMI · Phase 2, Interventional, and Treatment
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.
Primary PCI opens blocked heart arteries during a heart attack but can cause additional injury when blood flow returns. This is called reperfusion injury and accounts for up to half of the final heart damage. No drug given at the time of this procedure has been proven to reduce this injury in routine practice.
Laboratory studies suggest empagliflozin, a drug approved for diabetes and heart failure, may protect the heart when given before blood flow is restored. It may work by reducing harmful chemical changes inside heart cells, protecting mitochondria, and lowering inflammation. However, it is not known if empagliflozin must be given before the procedure to work, or if giving it afterward works just as well. Prior large studies gave empagliflozin days after heart attacks and could not test this question. Smaller pre-procedure studies had mixed results.
This trial answers one main question: does the timing of empagliflozin matter for protecting the heart during a heart attack? It compares giving the drug before the procedure, within 2 hours after the procedure, or a placebo. This is a Phase II trial designed to provide information needed to plan a larger future trial.
The trial enrolls 480 South Asian adults aged 18 to 75 having their first heart attack and scheduled for primary PCI within 12 hours of symptom onset. Participants are randomly assigned to one of three groups. Group A receives empagliflozin 25 mg before the procedure and placebo afterward. Group B receives placebo before and empagliflozin 25 mg within 2 hours after successful PCI. Group C receives placebo at both times. All groups continue study pills once daily for 90 days. The double-dummy design keeps participants and researchers unaware of group assignments.
Blood samples are taken at the procedure and at 6, 12, 24, and 48 hours afterward. These are sent to a central lab to measure troponin, a protein released when heart muscle is damaged. The total troponin released over 48 hours is the main measure of heart injury. Additional blood tests measure other heart function and inflammation markers.
Echocardiograms, ultrasound images of the heart, are done at Day 3, Day 30, and Day 90 to measure how well the heart pumps blood. At least 120 participants at CMR-capable sites will have a cardiac MRI between Day 3 and Day 5 to confirm troponin findings.
A substudy measures empagliflozin levels in the blood at balloon inflation in all Group A participants. A smaller group has additional blood samples over 24 hours to study drug absorption. These measurements test whether higher drug levels at balloon inflation lead to lower heart injury.
The trial takes place at five heart centres in Pakistan: Peshawar Institute of Cardiology, Lady Reading Hospital, Rehman Medical Institute, and Hayatabad Medical Complex in Peshawar, and Kulsoom International Hospital in Islamabad.
An independent Data Safety Monitoring Board reviews safety at three points during the trial, checking for kidney problems, diabetic ketoacidosis, infections, or other serious side effects. The trial has rules to stop or pause if safety issues arise.
Enrollment runs from August 2026 to May 2027. Each participant is followed for 90 days, with final follow-up completed by August 2027. Results are expected by September 2027.
Primary analysis uses ANCOVA, accounting for differences such as heart attack location, diabetes, symptom duration, and hospital. A fixed-sequence testing hierarchy controls for false positive findings: Arm A compared to Arm C first, then Arm A to Arm B, then Arm B to Arm C.
850 studies on the registry are indexed under ST Elevation Myocardial Infarction; 197 are open to participants now.
This study's planned enrollment of 480 is above the median of 194 across 527 interventional studies indexed under ST Elevation Myocardial Infarction.
Browse ST Elevation Myocardial Infarction studies →Rehman Medical Institute - RMI is the lead sponsor of 24 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: empagliflozin · Drug: Placebo
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.
Drug: empagliflozin · Drug: 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.
Drug: Placebo
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.
Also known as: Jardiance
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.
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
Time frame: 0-48 hours after successful reperfusion by primary PCI
Plan to share: Yes — De-identified individual participant data underlying the primary and secondary outcomes, the statistical analysis code, and the full Statistical Analysis Plan will be made available to qualified researchers on reasonable request, beginning after publication of the primary results manuscript, subject to Institutional Review Board approval at the requesting institution and execution of a data-sharing agreement with the coordinating site.
Supporting information: Statistical analysis plan, Analytic code
Time frame: Individual participant data, the statistical analysis code, and the Statistical Analysis Plan will become available beginning 9 months after publication of the primary results manuscript and will remain available for 36 months thereafter.
Access criteria: Available to qualified researchers who submit a scientifically sound research proposal to the Coordinating Principal Investigator. Requestors must provide institutional affiliation, a written proposal, and evidence of their own institutional ethics approval. Access is granted only after execution of a data-sharing agreement with the coordinating site (Rehman Medical Institute, Peshawar) and is limited to de-identified individual participant data, the statistical analysis code, and the Statistical Analysis Plan, for the stated research purpose only.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.
Of 31 phase 2 interventional studies under ST Elevation Myocardial Infarction, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 39. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Empagliflozin
ST Elevation Myocardial Infarction →
Rehman Medical Institute - RMI