ISGLT2 in Patients Without DM With Acute MI

Active, not recruiting

• Conditions: Acute Coronary Syndromes; Heart Failure
• Interventions: Drug: With ISGLT2

• Registration Number: NCT06903754
• Lead Sponsor: Mohammed VI University Hospital

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.

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 Timeline

• Study Start: 2021-10-01
• Primary Completion: 2024-12-31
• Status Verified: 2025-03
• Study First Submitted: 2025-03-22
• Study First Submitted QC: 2025-03-28
• Last Update Submitted: 2025-03-28
• Study First Posted: 2025-04-01
• Last Update Posted: 2025-04-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Not provided

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Without ISGLT2	With ISGLT2	Patients for whom we will not prescribe ISGLT2

Primary Outcome Measures

Name	Time	Method
Primary endpoints	50 months	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

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes	50 months	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 \[Time Frame: From admission visit (Day 0) up to approximately 4.2 years\]

Trial Locations

Locations (1)

Mohammed VI university hospital oujda; 🇲🇦 Ouda, Morocco