NCT07297589

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P25-P50 for phase_3

Timeline
10mo left

Started Dec 2025

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Dec 2025Mar 2027

First Submitted

Initial submission to the registry

December 9, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 22, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

December 30, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

December 9, 2025

Last Update Submit

December 30, 2025

Conditions

STEMI - ST Elevation Myocardial InfarctionEpicardial Fat

Keywords

Epicardial fatSTEMISemaglutideDapagliflozin

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (4)

  • Change in LDL

    12 months

  • Change in fasting glucose and HbA1c

    12 months

  • Major adverse cardiovascular events (MACE)

    12 months

  • Change in body weight

    12 months

Study Arms (2)

Dapagliflozin

EXPERIMENTAL

Dapagliflozin 10 mg daily

Drug: Dapagliflozin 10 MG Oral Tablet

Semaglutide

ACTIVE COMPARATOR

Semaglutide 3 mg, gradually increasing to 14 mg every 24 hours

Drug: Semaglutide (Rybelsus®)

Interventions

Dapagliflozin 10 MG Oral TabletDRUG

10 mg of dapagliflozin daily for 12 months

Dapagliflozin
Semaglutide (Rybelsus®)DRUG

Semaglutide 3 mg, gradually increasing to 14 mg every 24 hours for 12 months

Semaglutide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%.

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unidad Medica de Alta Especialidad No. 1, Bajío

León, Guanajuato, 37260,, Mexico

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

dapagliflozinsemaglutide

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Rodolfo Guardado-Mendoza, Ph.D.

    Universidad de Guanajuato

    STUDY CHAIR

Central Study Contacts

Hilda Elizabeth Macías-Cervantes, Ph.D.

CONTACT

4777174800hildamacer@gmail.com

Rodolfo Guardado-Mendoza, Ph.D.

CONTACT

4772674900guardamen@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

December 9, 2025

First Posted

December 22, 2025

Study Start

December 30, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

January 2, 2026

Record last verified: 2025-12

Locations

ME(1)