ISGLT2 in Patients Without DM With Acute MI

NCT06903754 | Completed FDA Drug

• 1 other identifier: DI657483
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Coronary Syndromes; Heart Failure

Keywords

Acute coronary syndronme; ISGLT2; Heart failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary outcomes

  50 months

Study Arms (1)

Without ISGLT2

Patients for whom we will not prescribe ISGLT2

Drug: With ISGLT2

Interventions

With ISGLT2 DRUG

Patients for whom we will prescribe ISGLT2

Without ISGLT2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with Acute coronary syndrome

You may qualify if:

• 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).

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Mohammed VI University Hospital: lead

Study Sites (1)

Mohammed VI university hospital oujda

OUDA, Morocco

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Heart Failure

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CLINICAL CARDIOLOGIST

Study Record Dates

• First Submitted: March 22, 2025
• First Posted: April 1, 2025
• Study Start: October 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 15, 2025

Record last verified: 2025-03

Locations

MO (1)