ST-elevation Myocardial Infarction (STEMI)Phase 2TEMPO-STEMINCT07749014
Timing of Empagliflozin in Primary PCI: Pre-Reperfusion Versus Post-Reperfusion Versus Placebo in South Asian STEMI Patients
A Phase 2 study testing empagliflozin in people with ST-elevation Myocardial Infarction (STEMI) and Acute Myocardial Infarction (AMI), run by Rehman Medical Institute - RMI at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ST-elevation Myocardial Infarction (STEMI), Acute Myocardial Infarction (AMI), Coronary Artery Disease
- What is being tested?
- empagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2026to 30 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 18Show fewer
- 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 current presentation.
- Severe multivessel disease with anticipated need for urgent CABG within 48 hours.
- Cardiac arrest with coma (GCS <8) at presentation consent not obtainable and metabolic state unpredictable.
- Significant metabolic abnormality precluding oral drug: severe vomiting, nil-by-mouth status, or frank dehydration with SBP <100 mmHg on arrival.
- Concurrent participation in another interventional clinical trial.
- Life expectancy <6 months from a non-cardiac cause.
- Expected inability to attend the 90-day follow-up visit.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Rehman Medical Institute
Peshawar, Khyber Pakhtun Khwa, 25000
Syed Muhammad Rayyan, MBBS, +92 3369949269, drsmuhammadrayyan@gmail.com
Hammad Saif, MBBS, +92 334 9903737, hammadsaif7690@gmail.com
About this study
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:
Read more
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.
Read the detailed description
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.
- Conditions
- ST-elevation Myocardial Infarction (STEMI), Acute Myocardial Infarction (AMI), Coronary Artery Disease
- Being tested
- empagliflozin, Placebo
- Keywords
- Empagliflozin, SGLT2 Inhibitor, ST-elevation myocardial infarction, Primary Percutaneous Coronary Intervention, Primary PCI, Ischemia-Reperfusion Injury, Myocardial Infarction, Troponin I, Cardioprotection, South Asian Population
- Medical subject headings
- ST Elevation Myocardial Infarction, Coronary Artery Disease, Reperfusion Injury, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
empagliflozinDrug
Also called Jardiance
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.
PlaceboDrug
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 group | Role | What they receive |
|---|---|---|
| Pre-reperfusion Empagliflozin | Experimental | 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. Receives: Drug: empagliflozin; Drug: Placebo |
| Post-reperfusion Empagliflozin | Experimental | 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. Receives: Drug: empagliflozin; Drug: Placebo |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0-48 hours after successful reperfusion by primary PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST-elevation Myocardial Infarction (STEMI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm, double-dummy parallel design. Every participant receives one pre-PCI and one post-PCI dose pack on an identical schedule, so administration sequence cannot reveal allocation. Arm A: empagliflozin 25 mg loading immediately after randomization, before cath-lab transfer (no PCI delay), plus matched placebo post-PCI. Arm B: matched placebo pre-PCI plus empagliflozin 25 mg loading within 2 hours after successful PCI. Arm C: matched placebo at both timepoints. All arms then continue blinded empagliflozin 10 mg once daily or matched placebo for 90 days, so total drug exposure is equal across active arms and only loading-dose timing differs. Randomization is 1:1:1 via variable block sizes, stratified by site, diabetes status, and infarct territory.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rehman Medical Institute - RMI
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan State University
- Responsible party
- Principal investigator, Miqdad Ali Khan, Rehman Medical Institute - RMI
- Investigators
- Miqdad A Khan, MD, FACC, FISCI, FSCAI, FACP, Principal investigator, Rehman Medical InstituteHerbert D Aronow, MD, MPH, MSCAI, FACC, MSVM, Study chair, Michigan State University College of Human MedicineAshraf S Niazi, MBBS, FRCP, Study director, Northampton General Hospital, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749014
- Sponsor's protocol ID
- RMI/IRB-EC/2026/020
- Acronym
- TEMPO-STEMI
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Empagliflozin in Primary PCI: Pre-Reperfusion Versus Post-Reperfusion Versus Placebo in South Asian STEMI Patients
- ClinicalTrials.gov ID
- NCT07749014
- Acronym / sponsor ID
- TEMPO-STEMI / RMI/IRB-EC/2026/020
- Conditions
- ST-elevation Myocardial Infarction (STEMI), Acute Myocardial Infarction (AMI), Coronary Artery Disease
- Keywords
- Empagliflozin, SGLT2 Inhibitor, ST-elevation myocardial infarction, Primary Percutaneous Coronary Intervention, Primary PCI, Ischemia-Reperfusion Injury, Myocardial Infarction, Troponin I
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Rehman Medical Institute - RMIUniversity, hospital or other
- Collaborators
- Michigan State University
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Three-arm, double-dummy parallel design. Every participant receives one pre-PCI and one post-PCI dose pack on an identical schedule, so administration sequence cannot reveal allocation. Arm A: empagliflozin 25 mg loading immediately after randomization, before cath-lab transfer (no PCI delay), plus matched placebo post-PCI. Arm B: matched placebo pre-PCI plus empagliflozin 25 mg loading within 2 hours after successful PCI. Arm C: matched placebo at both timepoints. All arms then continue blinded empagliflozin 10 mg once daily or matched placebo for 90 days, so total drug exposure is equal across active arms and only loading-dose timing differs. Randomization is 1:1:1 via variable block sizes, stratified by site, diabetes status, and infarct territory.
| Arm | Type | Receives |
|---|---|---|
| Pre-reperfusion Empagliflozin | Experimental | Drug: empagliflozin, Drug: PlaceboParticipants 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. |
| Post-reperfusion Empagliflozin | Experimental | Drug: empagliflozin, Drug: PlaceboParticipants 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 | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| empagliflozinAlso: JardianceEmpagliflozin 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 | Post-reperfusion Empagliflozin, Pre-reperfusion Empagliflozin |
| PlaceboParticipants 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. | Drug | Placebo, Post-reperfusion Empagliflozin, Pre-reperfusion Empagliflozin |
Primary outcome
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Miqdad A Khan, MD, FACC, FISCI, FSCAI, FACP principal investigator
Rehman Medical Institute
Herbert D Aronow, MD, MPH, MSCAI, FACC, MSVM study chair
Michigan State University College of Human Medicine
Ashraf S Niazi, MBBS, FRCP study director
Northampton General Hospital, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing empagliflozin in people with ST-elevation Myocardial Infarction (STEMI) and Acute Myocardial Infarction (AMI), run by Rehman Medical Institute - RMI at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Syed M Rayyan, MBBS (+923369949269, drsmuhammadrayyan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.