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300 STIMI patients with LV systolic dysfunction will be divided into two equal groups (Group I (Study arm, n=150); will receive dapagliflozin plus conventional therapy and group (II) Control arm (n=150); will receive conventional therapy only to detect an improvement in the LVEF by ≥ 5
300 STIMI patients with LV systolic dysfunction will be randomly divided into two equal groups (Group I (Study arm, n=150); will receive
Group (II) Control arm (n=150); will receive
Laboratory investigation substudy analysis:
50 patients from either group will undergo NT-proBNP at baseline and after 3 month follow up.
Clinical outcomes:
Patients will be followed up in a deducted outpatient clinic for assessment of clinical outcomes either by phone cell or clinic visits at 3 month.
Patients will be assessed for the following clinical parameters:
I. Composite of CV death and rehospitalization of HF. II. Individual component at composite end points. III. Reinfarction or readmission for ACS and target lesion revascularization.
Research outcome measures:
a. Primary (main):
1. The improvement in the LVEF (≥ 5%) using biplane simpson method echocardiography.
a. Secondary (subsidiary):
Echocardiographic parameters at 3 month follow up.
Laboratory investigations. Changes of the NT-proBNP from baseline to 3 month follow up
Clinical outcomes at 3month. I. Composite of CV death and rehospitalization of HF. II. Individual component at composite end points. III. Reinfarction or readmission for ACS and target lesion revascularization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dapagliflozin | Active Comparator | (a) Dapagliflozin 10 mg once daily within 24 hours after PPCI for 3 month |
|
| conventional therapy | Placebo Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin 10Mg Tab | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Echocardiographic parameter | The improvement in the LVEF (≥ 5%) using biplane simpson method echocardiography | 3 month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in LV remodeling | using echocardiography | 3 month follow up |
| Changes in diastolic function | using mitral Inflow Patterns electrocardiography |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| D018487 | Ventricular Dysfunction, Left |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
| D001241 | Aspirin |
| D000077486 | Ticagrelor |
| C028145 | 2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosine |
| D000319 | Adrenergic beta-Antagonists |
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| D000806 | Angiotensin-Converting Enzyme Inhibitors |
| D057911 | Angiotensin Receptor Antagonists |
| D000451 | Mineralocorticoid Receptor Antagonists |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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|
|
| Placebo | Drug |
|
|
|
| 3 month follow up |
| Changes in LA volume index | using by the biplane area-length method from apical 4- and 2-chamber views electrocardiography | 3 month follow up |
| Changes in LV mass index. | using by linear method electrocardiography | 3 month follow up |
| Laboratory investigations. | Changes of the NT-proBNP from baseline to 3 month follow up | 3 month follow up |
| CV death and rehospitalization of HF | Composite of CV death and rehospitalization of HF | 3 month follow up |
| Individual component at composite end points. | Composite of CV death or rehospitalization of HF | 3 month follow up |
| ACS | Reinfarction or readmission for ACS and target lesion revascularization. | 3 month follow up |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D018754 | Ventricular Dysfunction |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D018674 | Adrenergic Antagonists |
| D018663 | Adrenergic Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |
| D011480 | Protease Inhibitors |
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D062865 | Diuretics, Potassium Sparing |
| D004232 | Diuretics |
| D045283 | Natriuretic Agents |