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

Sponsor
Mohammad Hussien Tantawy Soliman (Other)
Overall Status
Recruiting
CT.gov ID
NCT06009874
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
34
Anticipated Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dapagliflozin 10mg Tab
  • Drug: Placebo
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Prevention
Official Title:
Clinical Investigation of Cardioprotective Effect of Early Administration of Sodium-glucose Cotransport-2 Inhibitors in Patients With Acute Myocardial Infarction
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2026
Anticipated Study Completion Date :
Aug 1, 2026

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. difference in infarct size [3 months]

      infarct size measurement (percentage) for both groups

    2. difference in NT-proBNP level [3 months]

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

    Secondary Outcome Measures

    1. Difference in eGFR [3 months]

      Decline in eGFR (ml/min) for both groups

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mohammad Soliman Shibīn Al Kawm Menofia Egypt 32741

    Sponsors and Collaborators

    • Mohammad Hussien Tantawy Soliman

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mohammad Hussien Tantawy Soliman, Principal Investigator, Tanta University
    ClinicalTrials.gov Identifier:
    NCT06009874
    Other Study ID Numbers:
    • 35541/6/22
    First Posted:
    Aug 24, 2023
    Last Update Posted:
    Aug 24, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Myocardial Infarction
    Infarction
    Dapagliflozin

    Study Results

    No Results Posted as of Aug 24, 2023