The Effect of Early Administration of Dapagliflozin in STEMI Patients With LV Systolic Dysfunction

NCT05045274 | Unknown

• 1 other identifier: GAgban
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

STEMI - ST Elevation Myocardial Infarction; Left Ventricular Systolic Dysfunction

Outcome Measures

Primary Outcomes (1)

• Echocardiographic parameter

  The improvement in the LVEF (≥ 5%) using biplane simpson method echocardiography

  3 month follow up

Secondary Outcomes (8)

• Changes in LV remodeling

  3 month follow up

• Changes in diastolic function

  3 month follow up

• Changes in LA volume index

  3 month follow up

• Changes in LV mass index.

  3 month follow up

• Laboratory investigations.

  3 month follow up

Study Arms (2)

dapagliflozin

ACTIVE COMPARATOR

(a) Dapagliflozin 10 mg once daily within 24 hours after PPCI for 3 month

Drug: Dapagliflozin 10Mg Tab

conventional therapy

PLACEBO COMPARATOR

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

Interventions

Dapagliflozin 10Mg Tab DRUG

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.

dapagliflozin

Placebo DRUG

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.

conventional therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• st time STEMI within 24 hours undergoing PPCI. (Chest pain \> 30 minutes and ST segment elevation in more than one lead, include the definition of MI with a reference: Third universal definition of MI. (published at ESC Clinical Practice Guidelines 2012).
• LVEF less than 50%.
• eGFR ≥20 mL/min/1.73 m2.

You may not qualify if:

• Patients less than 18 years old.
• T1D (Type I diabetes mellitus).
• Hemodynamically unstable.
• Cardiogenic shock (clinical syndrome of tissue hypoperfusion resulting from cardiac dysfunction).
• History of chronic symptomatic HF with a prior hHF within last year
• Patients on dialysis.
• Serious hypersensitivity to dapagliflozin (eg, anaphylaxis, angioedema).
• Pregnant or lactating women.
• Sever hepatic impairment.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Ventricular Dysfunction, Left

Interventions

dapagliflozin; Aspirin; Ticagrelor; 2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosine; Adrenergic beta-Antagonists; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Angiotensin-Converting Enzyme Inhibitors; Angiotensin Receptor Antagonists; Mineralocorticoid Receptor Antagonists

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Ventricular Dysfunction

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses; Protease Inhibitors; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Diuretics, Potassium Sparing; Diuretics; Natriuretic Agents

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 16, 2021
• Study Start: December 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 16, 2021

Record last verified: 2021-09