Myocardial InfarctionNCT06009874
Clinical Investigation of the Cardioprotective Effect of Early Administration of SGLT2 in Patients Presented With AMI
A study testing Dapagliflozin 10mg Tab in people with Myocardial Infarction, run by Mohammad Hussien Tantawy Soliman at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Dapagliflozin 10mg Tab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2023to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Cardiogenic shock.
- Hypoglycemia.
- History of diabetic ketoacidosis.
- Genital and urinary infections.
- History of AMI.
- Stent thrombosis.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Mohammad Soliman
Shibīn al Kawm, Menofia, 32741
Mohammad Soliman, dr.mhtantawy@gmail.com
About this study
Official title: Clinical Investigation of Cardioprotective Effect of Early Administration of Sodium-glucose Cotransport-2 Inhibitors in Patients With Acute Myocardial Infarction
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.
Read the 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
- Conditions
- Myocardial Infarction
- Being tested
- Dapagliflozin 10mg Tab, Placebo
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10mg TabDrug
Also called DAPA
patients will be treated with DAPA 10 mg once daily for three months
PlaceboDrug
patients will be treated with a placebo tab once daily for three months
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin group | Active comparator | patients with MI will be treated with DAPA 10 mg once daily for three months. Receives: Drug: Dapagliflozin 10mg Tab |
| Placebo group | Placebo comparator | patients with MI will be treated with a matching placebo once daily for three months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in infarct size
infarct size measurement (percentage) for both groups
Measured: 3 months
difference in NT-proBNP level
NT-proBNP level (pg/ml) for both groups
Measured: 3 months
Secondary outcomes (1)
Difference in eGFR
Decline in eGFR (ml/min) for both groups
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start20 Dec 2023
- Primary completionOct 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohammad Hussien Tantawy Soliman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohammad Hussien Tantawy Soliman, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009874
- Sponsor's protocol ID
- 35541/6/22
- Status last verified
- Oct 2026
- First submitted
- 11 Aug 2023
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of Cardioprotective Effect of Early Administration of Sodium-glucose Cotransport-2 Inhibitors in Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT06009874
- Acronym / sponsor ID
- 35541/6/22
- Conditions
- Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mohammad Hussien Tantawy SolimanUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin group | Active comparator | Drug: Dapagliflozin 10mg Tabpatients with MI will be treated with DAPA 10 mg once daily for three months. |
| Placebo group | Placebo comparator | Drug: Placebopatients with MI will be treated with a matching placebo once daily for three months. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- Cardiogenic shock.
- Hypoglycemia.
- History of diabetic ketoacidosis.
- Genital and urinary infections.
- History of AMI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin 10mg TabAlso: DAPApatients will be treated with DAPA 10 mg once daily for three months | Drug | Dapagliflozin group |
| Placebopatients will be treated with a placebo tab once daily for three months | Drug | Placebo group |
Primary outcome
difference in infarct size
Time frame: 3 months
infarct size measurement (percentage) for both groups
difference in NT-proBNP level
Time frame: 3 months
NT-proBNP level (pg/ml) for both groups
1 secondary outcome
Difference in eGFR
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dapagliflozin 10mg Tab in people with Myocardial Infarction, run by Mohammad Hussien Tantawy Soliman at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Soliman (+201003474565, dr.mhtantawy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in infarct size (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.