Clinical Investigation of the Cardioprotective Effect of Early Administration of SGLT2 in Patients Presented With AMI
Clinical Investigation of Cardioprotective Effect of Early Administration of Sodium-glucose Cotransport-2 Inhibitors in Patients With Acute Myocardial Infarction
1 other identifier
interventional
80
1 country
1
Brief Summary
This study aims to investigate the effect of early administration of DAPA during ischemia and before pPCI on infarct size, reperfusion injury-related myocardial damage, cardioprotection from HF, and renoprotection from AKI in patients with AMI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2023
CompletedFirst Posted
Study publicly available on registry
August 24, 2023
CompletedStudy Start
First participant enrolled
October 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
August 24, 2023
August 1, 2023
2.8 years
August 11, 2023
August 18, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
difference in infarct size
infarct size measurement (percentage) for both groups
3 months
difference in NT-proBNP level
NT-proBNP level (pg/ml) for both groups
3 months
Secondary Outcomes (1)
Difference in eGFR
3 months
Study Arms (2)
Dapagliflozin group
ACTIVE COMPARATORpatients with MI will be treated with DAPA 10 mg once daily for three months.
Placebo group
PLACEBO COMPARATORpatients with MI will be treated with a matching placebo once daily for three months.
Interventions
patients will be treated with DAPA 10 mg once daily for three months
Eligibility Criteria
You may qualify if:
- Patients with ST-elevation myocardial infarction (STEMI).
- STEMI was defined according to the Fourth Universal Definition of AMI.
- years of age.
- Diabetics or non-diabetics.
- eGFR \> 45 ml/min/1.73m2.
- Blood pressure before first drug dosing \>110/70 mmHg.
You may not qualify if:
- Cardiogenic shock.
- Hypoglycemia.
- History of diabetic ketoacidosis.
- Genital and urinary infections.
- History of AMI.
- Stent thrombosis.
- Previous coronary artery bypass surgery.
- Severe hepatic insufficiency.
- Advanced cancer patients.
- Blood pH \< 7.32.
- Known allergy to SGLT-2 inhibitors.
- Hemodynamic instability.
- Females of childbearing potential without adequate contraceptive methods.
- Patients currently on or have received any SGLT-2 inhibitors.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mohammad Soliman
Shibīn al Kawm, Menofia, 32741, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 11, 2023
First Posted
August 24, 2023
Study Start
October 1, 2023
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
August 24, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share