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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06009874

Enrollment

Registered

2023-08-24

Start date

2023-10-31

Completion date

2026-08-31

Last updated

2023-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

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.

Detailed description

DAPA was approved for HF patients, but there is no sufficient data about its efficacy on patients with AMI and if it can protect from the development of HF after AMI. the investigators aim to investigate the effect of DAPA on patients who presented with AMI when administered as early as possible before pPCI and to be continued for three months after there. the effect of DAPA on infarct size, cardiac biomarkers will be assessed during the follow-up period

Interventions

DRUGDapagliflozin 10mg Tab

patients will be treated with DAPA 10 mg once daily for three months

DRUGPlacebo

patients will be treated with a placebo tab once daily for three months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Patients with ST-elevation myocardial infarction (STEMI). 2. STEMI was defined according to the Fourth Universal Definition of AMI. 3. 18 - 80 years of age. 4. Diabetics or non-diabetics. 5. eGFR \> 45 ml/min/1.73m2. 6. Blood pressure before first drug dosing \>110/70 mmHg.

Exclusion criteria

1. Cardiogenic shock. 2. Hypoglycemia. 3. History of diabetic ketoacidosis. 4. Genital and urinary infections. 5. History of AMI. 6. Stent thrombosis. 7. Previous coronary artery bypass surgery. 8. Severe hepatic insufficiency. 9. Advanced cancer patients. 10. Blood pH \< 7.32. 11. Known allergy to SGLT-2 inhibitors. 12. Hemodynamic instability. 13. Females of childbearing potential without adequate contraceptive methods. 14. Patients currently on or have received any SGLT-2 inhibitors.

Design outcomes

Primary

Measure	Time frame	Description
difference in infarct size	3 months	infarct size measurement (percentage) for both groups
difference in NT-proBNP level	3 months	NT-proBNP level (pg/ml) for both groups

Secondary

Measure	Time frame	Description
Difference in eGFR	3 months	Decline in eGFR (ml/min) for both groups

Countries

Egypt

Contacts

Primary ContactMohammad Soliman

dr.mhtantawy@gmail.com+201003474565

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026