Clinical Investigation of the Cardioprotective Effect of Early Administration of SGLT2 in Patients Presented With AMI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dapagliflozin 10mg Tab, Placebo.
- Who it may be relevant to
- Registry conditions: Myocardial Infarction. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Investigation of Cardioprotective Effect of Early Administration of Sodium-glucose Cotransport-2 Inhibitors in Patients With Acute Myocardial Infarction
Overview
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
Interventions
- Drug Dapagliflozin 10mg Tab
patients will be treated with DAPA 10 mg once daily for three months - Drug Placebo
patients will be treated with a placebo tab once daily for three months
Primary outcome measures
- difference in infarct size [Time frame: 3 months]
- difference in NT-proBNP level [Time frame: 3 months]
Secondary outcome measures (1)
- Difference in eGFR [Time frame: 3 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Mohammad Soliman — Shibīn al Kawm
Identifiers
NCT: NCT06009874 · 35541/6/22