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
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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RECRUITING
NA
80 participants
INTERVENTIONAL
2023-10-31
2026-08-31
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Dapagliflozin group
patients with MI will be treated with DAPA 10 mg once daily for three months.
Dapagliflozin 10mg Tab
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.
Placebo
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
Placebo
patients will be treated with a placebo tab once daily for three months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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Mohammad Hussien Tantawy Soliman
OTHER
Responsible Party
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Mohammad Hussien Tantawy Soliman
Principal Investigator
Locations
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Mohammad Soliman
Shibīn al Kawm, Menofia, Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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35541/6/22
Identifier Type: -
Identifier Source: org_study_id
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