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NCT Number: NCT06009874

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mohammad Soliman

Shibīn al Kawm, Menofia, 32741, Egypt

Location status: Recruiting

Location contact

Mohammad Soliman

CONTACT

[email protected]

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Dapagliflozin 10mg Tab

Drug

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

Other names: DAPA

Placebo

Drug

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

Primary outcomes

  1. difference in infarct size

    Time frame: 3 months

    infarct size measurement (percentage) for both groups

  2. difference in NT-proBNP level

    Time frame: 3 months

    NT-proBNP level (pg/ml) for both groups

Secondary outcomes

  1. Difference in eGFR

    Time frame: 3 months

    Decline in eGFR (ml/min) for both groups

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammad Soliman

CONTACT

[email protected]

+201003474565

Sponsors and collaborators

Lead sponsor

Mohammad Hussien Tantawy Soliman

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 24, 2023
Registry last updated
Aug 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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