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

NCT ID: NCT06009874

Last Updated: 2023-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-31

Study Completion Date

2026-08-31

Brief Summary

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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

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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

Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Dapagliflozin group

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

Group Type ACTIVE_COMPARATOR

Dapagliflozin 10mg Tab

Intervention Type DRUG

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

Placebo group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Dapagliflozin 10mg Tab

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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DAPA

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mohammad Hussien Tantawy Soliman

OTHER

Sponsor Role lead

Responsible Party

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Mohammad Hussien Tantawy Soliman

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Mohammad Soliman

Shibīn al Kawm, Menofia, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohammad Soliman

Role: CONTACT

+201003474565

Facility Contacts

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Mohammad Soliman

Role: primary

Other Identifiers

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35541/6/22

Identifier Type: -

Identifier Source: org_study_id

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