An interventional study of Dapagliflozin 10Mg Tab and Placebo in STEMI - ST Elevation Myocardial Infarction and Left Ventricular Systolic Dysfunction, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-16.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
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):
a. Secondary (subsidiary):
Echocardiographic parameters at 3 month follow up.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's planned enrollment of 300 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
(a) Dapagliflozin 10 mg once daily within 24 hours after PPCI for 3 month
Drug: Dapagliflozin 10Mg Tab
1. Reperfusion therapy: primary percutaneous coronary intervention (PPCI) after DAPT loading (aspirin 300 mg and either clopidogrel 600mg or ticagrelor 180 mg orally) in the ambulance or emergency department upon diagnosis. 2. Anti-ischemic treatment: DAPT, SC-anticoagulation, beta blockers, statin or others will be individualized according to the patient condition. 3. Anti-failure treatment: Angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, mineralocorticoid receptor antagonists, other diuretics will be added in case of volume overload.
Drug: Placebo
1. Dapagliflozin: It will be given in a dose of 10 mg once daily within 24 hours after PPCI. 2. Reperfusion therapy: primary percutaneous coronary intervention (PPCI) after DAPT loading (aspirin 300 mg and either clopidogrel 600mg or ticagrelor 180 mg orally) in the ambulance or emergency department upon diagnosis. 3. Anti-ischemic treatment: DAPT, SC-anticoagulation, beta blockers, statin or others will be individualized according to the patient condition. 4. Anti-failure treatment: Angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, mineralocorticoid receptor antagonists, other diuretics will be added in case of volume overload.
Also known as: aspirin 300 mg and either clopidogrel 600mg or ticagrelor 180 mg orally, DAPT, SC-anticoagulation, beta blockers, statin, Angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, mineralocorticoid receptor antagonists, other diuretics will be added in case of volume overload.
1. Reperfusion therapy: primary percutaneous coronary intervention (PPCI) after DAPT loading (aspirin 300 mg and either clopidogrel 600mg or ticagrelor 180 mg orally) in the ambulance or emergency department upon diagnosis. 2. Anti-ischemic treatment: DAPT, SC-anticoagulation, beta blockers, statin or others will be individualized according to the patient condition. 3. Anti-failure treatment: Angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, mineralocorticoid receptor antagonists, other diuretics will be added in case of volume overload.
Also known as: aspirin 300 mg and either clopidogrel 600mg or ticagrelor 180 mg orally, DAPT, SC-anticoagulation, beta blockers, statin, Angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, mineralocorticoid receptor antagonists, other diuretics will be added in case of volume overload.
Echocardiographic parameter
The improvement in the LVEF (≥ 5%) using biplane simpson method echocardiography
Time frame: 3 month follow up
Changes in LV remodeling
using echocardiography
Time frame: 3 month follow up
Changes in diastolic function
using mitral Inflow Patterns electrocardiography
Time frame: 3 month follow up
Changes in LA volume index
using by the biplane area-length method from apical 4- and 2-chamber views electrocardiography
Time frame: 3 month follow up
Changes in LV mass index.
using by linear method electrocardiography
Time frame: 3 month follow up
Laboratory investigations.
Changes of the NT-proBNP from baseline to 3 month follow up
Time frame: 3 month follow up
CV death and rehospitalization of HF
Composite of CV death and rehospitalization of HF
Time frame: 3 month follow up
Individual component at composite end points.
Composite of CV death or rehospitalization of HF
Time frame: 3 month follow up
ACS
Reinfarction or readmission for ACS and target lesion revascularization.
Time frame: 3 month follow up
No study locations are listed for this record.
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Assiut University