STEMI - ST Elevation Myocardial InfarctionPhase 3EPIC-CTNCT07297589
Epicardial Cardiac Fat-CT (EPIC-CT)
A Phase 3 study testing Dapagliflozin 10 MG Oral Tablet and Semaglutide (Rybelsus®) in people with STEMI - ST Elevation Myocardial Infarction and Epicardial Fat, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
Both globally and nationally, heart disease remains the leading cause of death overall and across genders, with ischemic heart disease being the primary cause. It is now understood that multiple risk factors contribute to the development of this condition, notably type 2 diabetes mellitus and obesity, especially an… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI - ST Elevation Myocardial Infarction, Epicardial Fat
- What is being tested?
- Dapagliflozin 10 MG Oral Tablet and Semaglutide (Rybelsus®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteMexico
- Study dates
- 30 Dec 2025to Mar 2027
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Criteria for the fourth definition of acute myocardial infarction with and without ST-segment elevation.
- Diagnosed with type 2 diabetes.
- Initial serum high-sensitivity CRP value > 2.0 mg/L.
- Clinically obese.
- LVEF >50%.
Who cannot join
- Patients who have recently received immunosuppressive therapy
- Patients with a history of ischemic heart disease
- Known allergy to any of the medications used
- Use of any of the study drugs more than 6 months prior to randomization
- Patients experiencing diabetic ketoacidosis
- Patients with hemodynamic instability (mean arterial pressure <60 mmHg while on vasopressors)
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- Pregnant women
- Patients with a history or current diagnosis of cancer
- Patients with documented active infections, such as pneumonia or urinary tract infections
- Patients with pancreatitis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Unidad Medica de Alta Especialidad No. 1, Bajío
León, Guanajuato, 37260,
Hilda E Macias Cervantes, master in clinical research, liz_2787@hotmail.com
About this study
Official title: Epicardial Cardiac Fat Comparative Trial
Both globally and nationally, heart disease remains the leading cause of death overall and across genders, with ischemic heart disease being the primary cause. It is now understood that multiple risk factors contribute to the development of this condition, notably type 2 diabetes mellitus and obesity, especially an increase in visceral fat. Among these, the role of epicardial fat volume in the presence of atheromatous plaques in patients with coronary artery disease has been emphasized, along with the link between its volume and the risk of ischemic cardiovascular events. Consequently, recent decades have seen focused research on the potential of epicardial fat as a marker for major adverse cardiac events and on strategies to reduce its volume as a treatment goal for patients with risk factors.
Selective sodium-glucose cotransporter 2 inhibitors are drugs that, beyond their antihyperglycemic effect, have demonstrated cardiovascular benefits through various mechanisms, including a reduction in epicardial fat. This was supported by a previous study conducted by our research group, although no statistically significant difference was found. On the other hand, GLP-1 agonists are effective drugs for weight control in patients with severe obesity. However, little research has been done on their effect on more localized fat, such as epicardial fat.
Read the detailed description
This randomized, open-label clinical trial will assess the effects of dapagliflozin compared to semaglutide on epicardial fat in patients with ST-segment elevation myocardial infarction and non-ST-segment elevation myocardial infarction over a 12-month period. Epicardial fat will be measured by simple coronary tomography during initial hospitalization for infarction and after 12 months of treatment with both medications.
It will include patients over 18 years old with STEMI and NSTEMI, with or without a diagnosis of type 2 diabetes and clinical obesity. Patients will be discharged following treatment guidelines, and their adherence to medication and tolerability will be monitored.
- Being tested
- Dapagliflozin 10 MG Oral Tablet, Semaglutide (Rybelsus®)
- Keywords
- Epicardial fat, STEMI, Semaglutide, Dapagliflozin
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10 MG Oral TabletDrug
10 mg of dapagliflozin daily for 12 months
Semaglutide (Rybelsus®)Drug
Semaglutide 3 mg, gradually increasing to 14 mg every 24 hours for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Experimental | Dapagliflozin 10 mg daily Receives: Drug: Dapagliflozin 10 MG Oral Tablet |
| Semaglutide | Active comparator | Semaglutide 3 mg, gradually increasing to 14 mg every 24 hours Receives: Drug: Semaglutide (Rybelsus®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epicardial fat
The volume of epicardial fat will be measured using simple coronary tomography during hospitalization for STEMI and after 12 months of treatment with both drugs to evaluate the change.
Measured: 12 months
Secondary outcomes (4)
Change in LDL
The effect of both interventions on LDL levels after 12 months of treatment will be evaluated.
Measured: 12 months
Change in fasting glucose and HbA1c
The impact of both interventions on changes in fasting glucose and HbA1c after 12 months of treatment will be assessed.
Measured: 12 months
Major adverse cardiovascular events (MACE)
During patient follow-up, the occurrence of cardiac failure events, whether requiring hospitalization or not, along with new acute myocardial infarction, cardiovascular death, or stroke, will be evaluated.
Measured: 12 months
Change in body weight
The effect of both interventions on body weight, expressed in kilograms, will be evaluated after 12 months of treatment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start30 Dec 2025
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMI - ST Elevation Myocardial InfarctionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hilda Elizabeth Macías Cervantes, Instituto Mexicano del Seguro Social
- Investigators
- Rodolfo Guardado-Mendoza, Ph.D., Study chair, Universidad de Guanajuato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297589
- Sponsor's protocol ID
- R-2025-1001-087
- Acronym
- EPIC-CT
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epicardial Cardiac Fat Comparative Trial
- ClinicalTrials.gov ID
- NCT07297589
- Acronym / sponsor ID
- EPIC-CT / R-2025-1001-087
- Keywords
- Epicardial fat, STEMI, Semaglutide, Dapagliflozin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 30 Dec 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 22 Dec 2025 (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.
Both globally and nationally, heart disease remains the leading cause of death overall and across genders, with ischemic heart disease being the primary cause. It is now understood that multiple risk factors contribute to the development of this condition, notably type 2 diabetes mellitus and obesity, especially an increase in visceral fat. Among these, the role of epicardial fat volume in the presence of atheromatous plaques in patients with coronary artery disease has been emphasized, along with the link between its volume and the risk of ischemic cardiovascular events. Consequently, recent decades have seen focused research on the potential of epicardial fat as a marker for major adverse cardiac events and on strategies to reduce its volume as a treatment goal for patients with risk factors.
Selective sodium-glucose cotransporter 2 inhibitors are drugs that, beyond their antihyperglycemic effect, have demonstrated cardiovascular benefits through various mechanisms, including a reduction in epicardial fat. This was supported by a previous study conducted by our research group, although no statistically significant difference was found. On the other hand, GLP-1 agonists are effective drugs for weight control in patients with severe obesity. However, little research has been done on their effect on more localized fat, such as epicardial fat.
Detailed description
This randomized, open-label clinical trial will assess the effects of dapagliflozin compared to semaglutide on epicardial fat in patients with ST-segment elevation myocardial infarction and non-ST-segment elevation myocardial infarction over a 12-month period. Epicardial fat will be measured by simple coronary tomography during initial hospitalization for infarction and after 12 months of treatment with both medications.
It will include patients over 18 years old with STEMI and NSTEMI, with or without a diagnosis of type 2 diabetes and clinical obesity. Patients will be discharged following treatment guidelines, and their adherence to medication and tolerability will be monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Experimental | Drug: Dapagliflozin 10 MG Oral TabletDapagliflozin 10 mg daily |
| Semaglutide | Active comparator | Drug: Semaglutide (Rybelsus®)Semaglutide 3 mg, gradually increasing to 14 mg every 24 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Criteria for the fourth definition of acute myocardial infarction with and without ST-segment elevation.
Key exclusion criteria (10 listed)
- Patients who have recently received immunosuppressive therapy
- Patients with a history of ischemic heart disease
- Known allergy to any of the medications used
- Use of any of the study drugs more than 6 months prior to randomization
- Patients experiencing diabetic ketoacidosis
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 |
|---|---|---|
| Dapagliflozin 10 MG Oral Tablet10 mg of dapagliflozin daily for 12 months | Drug | Dapagliflozin |
| Semaglutide (Rybelsus®)Semaglutide 3 mg, gradually increasing to 14 mg every 24 hours for 12 months | Drug | Semaglutide |
Primary outcome
Epicardial fat
Time frame: 12 months
The volume of epicardial fat will be measured using simple coronary tomography during hospitalization for STEMI and after 12 months of treatment with both drugs to evaluate the change.
4 secondary outcomes
Change in LDL
Time frame: 12 months
Change in fasting glucose and HbA1c
Time frame: 12 months
Major adverse cardiovascular events (MACE)
Time frame: 12 months
Change in body weight
Time frame: 12 months
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 2 Jan 2026.
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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.
Rodolfo Guardado-Mendoza, Ph.D. study chair
Universidad de Guanajuato
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dapagliflozin 10 MG Oral Tablet and Semaglutide (Rybelsus®) in people with STEMI - ST Elevation Myocardial Infarction and Epicardial Fat, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 2 Jan 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 Mexico. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Hilda Elizabeth Macías-Cervantes, Ph.D. (4777174800 ext. 31315, hildamacer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epicardial fat (time frame: 12 months). 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 2 Jan 2026.