ISGLT2 in Patients Without DM With Acute MI (ISGTL2-MORMI)

Sodium Glucose Cotransporter 2 Inhibitors in Patients Without Diabetes With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention

This study will evaluate the effect of ISGLT2 (Dapagliflozin or Empalgliflozin), administered once daily in addition to standard of care treatments for non-diabetic patients with myocardial infarction (MI) treated with PCI, on hospitalization for heart failure, readmissions for acute coronary syndrome and all-cause mortality.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Acute Coronary Syndromes
• Intervention / Treatment: Drug: With ISGLT2

Detailed Description

This is a single-center, prospective study in non-diabetic patients with acute coronary syndrome (ACS) (ST elevation (STEMI) or non-ST elevation (NSTEMI) with left ventricular systolic dysfunction (Defined as Ejection Fraction<50% assessed by 2D Simson Bi-plane echocardiography) or evidence of acute de Novo heart failure. The study will assess the effect of dapagliflozin or empagliflozin versus placebo, administered once daily in addition to standard therapy, on HF hospitalizations, all-cause deaths and ACS readmissions.

• Study Type: Observational
• Enrollment (Actual): 450

Contacts and Locations

Study Locations

• Morocco
  • OUDA, Morocco
    • Mohammed VI university hospital oujda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patient with Acute coronary syndrome

Description

Inclusion Criteria :

• Participant must approved the informed consent.
• Confirmed MI, either STEMI or NSTEMI, according to the fourth universal definition of MI (Thygesen et al 2019).
• Evidence of impaired regional or global LV systolic function at any timepoint during current MI-related hospitalisation with Ejection Fraction<50%(established with echocardiogram, radionuclide ventriculogram, contrast angiography or cardiac MRI) or Symptoms of Acute heart failure without cardiogenic Shock.
• Hemodynamically stable (no episodes of symptomatic hypotension, or arrhythmia with haemodynamic compromise in the last 24 hours).

Exclusion Criteria:

• Known type 1 diabetes mellitus (T1DM) or T2DM at the time for admission.
• Chronic symptomatic HF with a prior HHF within the last year and known reduced ejection fraction (LVEF≤40 %), documented before the current MI hospitalization.
• Patients with cardiogenic shock who received vasoactive drugs during index.
• Hospitalization Severe (eGFR <20 mL/min/1.73 m2 by local laboratory), unstable or rapidly progressing renal disease at the time of randomization
• Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into the trial.
• Active malignancy requiring treatment at the time of screening.
• Any non-CV condition, eg malignancy, with a life expectancy of less than one years based on the investigator´s clinical judgement.
• Currently on treatment, or with an indication for treatment, with a sodium glucose co-transporter 2 inhibitor (SGLT2-inhibitor)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Without ISGLT2; Patients for whom we will not prescribe ISGLT2	Drug: With ISGLT2; Patients for whom we will prescribe ISGLT2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary endpoints	Time to the first occurrence of any of the components of this composite: hospitalization for heart failure (HHF), Non fatal Myocardial infarction (MI) or Death from all causes	50 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary outcomes	Time to the first occurrence of a fatal or a non-fatal MI [Time Frame: From admission visit (Day 0) up to approximately 4.2years] Time to first hospitalisation for Heat failure [Time Frame: From admission visit (Day 0) up to approximately 3 years] Time to death of any cause [Time Frame: From admission visit (Day 0) up to approximately 4.2 years] Time to new onset of type 2 diabetes mellitus (T2DM) post discharge [Time Frame: From admission (Day 0) up to approximately 4.2 years] Time to new onset atrial fibrilation (AF) post discharge [Time Frame: From admission visit (Day 0) up to approximately 4.2 years]	50 months

Collaborators and Investigators

• Sponsor: Mohammed VI University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: March 22, 2025
• First Submitted That Met QC Criteria: March 28, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Heart failure; Acute coronary syndronme; ISGLT2
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Heart Failure; Acute Coronary Syndrome
• Other Study ID Numbers: DI657483

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No