Back to results

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

Primary Purpose

Myocardial Infarction

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Dapagliflozin 10mg Tab

Placebo

About this trial

This is an interventional prevention trial for Myocardial Infarction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Mohammad SolimanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dapagliflozin group

Placebo group

Arm Description

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

patients with MI will be treated with a matching placebo once daily for three months.

Outcomes

Primary Outcome Measures

difference in infarct size

infarct size measurement (percentage) for both groups

difference in NT-proBNP level

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

Secondary Outcome Measures

Difference in eGFR

Decline in eGFR (ml/min) for both groups

Full Information

NCT ID

NCT06009874

First Posted

August 11, 2023

Last Updated

August 18, 2023

Sponsor

Mohammad Hussien Tantawy Soliman

1. Study Identification

Unique Protocol Identification Number

NCT06009874

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 2023 (Anticipated)

Primary Completion Date

August 2026 (Anticipated)

Study Completion Date

August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Mohammad Hussien Tantawy Soliman

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dapagliflozin group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

patients with MI will be treated with a matching placebo once daily for three months.

Intervention Type

Drug

Intervention Name(s)

Dapagliflozin 10mg Tab

Other Intervention Name(s)

DAPA

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

difference in infarct size

Description

infarct size measurement (percentage) for both groups

Time Frame

3 months

Title

difference in NT-proBNP level

Description

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

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Difference in eGFR

Description

Decline in eGFR (ml/min) for both groups

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mohammad Soliman

Phone

+201003474565

dr.mhtantawy@gmail.com

Facility Information:

Facility Name

Mohammad Soliman

City

Shibīn Al Kawm

State/Province

Menofia

ZIP/Postal Code

32741

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mohammad Soliman

dr.mhtantawy@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs