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

August 18, 2023 updated by: Mohammad Hussien Tantawy Soliman

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Menofia
      • Shibīn Al Kawm, Menofia, Egypt, 32741

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dapagliflozin group
patients with MI will be treated with DAPA 10 mg once daily for three months.
Drug: Dapagliflozin 10mg Tab
patients will be treated with DAPA 10 mg once daily for three months
Other Names:
  • DAPA
Placebo Comparator: Placebo group
patients with MI will be treated with a matching placebo once daily for three months.
Drug: Placebo
patients will be treated with a placebo tab once daily for three months

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mohammad Hussien Tantawy Soliman

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

August 11, 2023

First Submitted That Met QC Criteria

August 18, 2023

First Posted (Actual)

August 24, 2023

Study Record Updates

Last Update Posted (Actual)

August 24, 2023

Last Update Submitted That Met QC Criteria

August 18, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35541/6/22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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