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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Without ISGLT2 | Patients for whom we will not prescribe ISGLT2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| With ISGLT2 | Drug | Patients for whom we will prescribe ISGLT2 |
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| 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 |
| 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] |
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Inclusion Criteria :
Exclusion Criteria:
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Patient with Acute coronary syndrome
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mohammed VI university hospital oujda | OUDA | Morocco |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| 50 months |