NCT06903754

ISGLT2 in Patients Without DM With Acute MI

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 450 (actual)
• Sponsor: Mohammed VI University Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Coronary Syndromes
• Heart Failure

Interventions

Type	Name	Description
DRUG	With ISGLT2	Patients for whom we will prescribe ISGLT2

Timeline

• Start date: 2021-10-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2025-04-01
• Last updated: 2025-09-15

Locations

1 site across 1 country: Morocco

Regulatory

• FDA-regulated drug study