Clinical Investigation of the Cardioprotective Effect of Early Administration of SGLT2 in Patients Presented With AMI

Myocardial Infarction Clinical Trial

Official title:

Clinical Investigation of Cardioprotective Effect of Early Administration of Sodium-glucose Cotransport-2 Inhibitors in Patients With Acute Myocardial Infarction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06009874
• Other study ID #: 35541/6/22
• Status: Recruiting
• Phase: N/A
• Start date: October 2023
• Est. completion date: August 2026

Study information

• Verified date: August 2023
• Source: Tanta University
• Contact: Mohammad Soliman
• Phone: +201003474565
• Email: dr.mhtantawy[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• Dapagliflozin 10mg Tab
patients will be treated with DAPA 10 mg once daily for three months
• Placebo
patients will be treated with a placebo tab once daily for three months

Locations

Country	Name	City	State
Egypt	Mohammad Soliman	Shibin Al Kawm	Menofia

Sponsors (1)

Lead Sponsor	Collaborator
Mohammad Hussien Tantawy Soliman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference in infarct size	infarct size measurement (percentage) for both groups	3 months
Primary	difference in NT-proBNP level	NT-proBNP level (pg/ml) for both groups	3 months
Secondary	Difference in eGFR	Decline in eGFR (ml/min) for both groups	3 months