Acute Coronary SyndromesISGTL2-MORMINCT06903754
ISGLT2 in Patients Without DM With Acute MI
An observational study of Acute Coronary Syndromes and Heart Failure, run by Mohammed VI University Hospital at 1 site in Morocco.
Trial summary
This study will evaluate the effect of ISGLT2 (Dapagliflozin or Empalgliflozin), administered once daily in addition to standard of care treatments for non-diabetic patients with myocardial infarction (MI) treated with PCI, on hospitalization for heart failure, readmissions for acute coronary syndrome and all-cause… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndromes, Heart Failure
- What is being tested?
- With ISGLT2
- How many people
- 450 participants
- Where
- 1 siteMorocco
- Study dates
- 1 Oct 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient with Acute coronary syndrome
Who may be able to join
- Participant must approved the informed consent.
- Confirmed MI, either STEMI or NSTEMI, according to the fourth universal definition of MI (Thygesen et al 2019).
- Evidence of impaired regional or global LV systolic function at any timepoint during current MI-related hospitalisation with Ejection Fraction<50%(established with echocardiogram, radionuclide ventriculogram, contrast angiography or cardiac MRI) or Symptoms of Acute heart failure without cardiogenic Shock.
- Hemodynamically stable (no episodes of symptomatic hypotension, or arrhythmia with haemodynamic compromise in the last 24 hours).
Who cannot join
- Known type 1 diabetes mellitus (T1DM) or T2DM at the time for admission.
- Chronic symptomatic HF with a prior HHF within the last year and known reduced ejection fraction (LVEF≤40 %), documented before the current MI hospitalization.
- Patients with cardiogenic shock who received vasoactive drugs during index.
- Hospitalization Severe (eGFR <20 mL/min/1.73 m2 by local laboratory), unstable or rapidly progressing renal disease at the time of randomization
- Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into the trial.
- Active malignancy requiring treatment at the time of screening.
- Any non-CV condition, eg malignancy, with a life expectancy of less than one years based on the investigator´s clinical judgement.
- Currently on treatment, or with an indication for treatment, with a sodium glucose co-transporter 2 inhibitor (SGLT2-inhibitor)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sodium Glucose Cotransporter 2 Inhibitors in Patients Without Diabetes With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention
This study will evaluate the effect of ISGLT2 (Dapagliflozin or Empalgliflozin), administered once daily in addition to standard of care treatments for non-diabetic patients with myocardial infarction (MI) treated with PCI, on hospitalization for heart failure, readmissions for acute coronary syndrome and all-cause mortality.
Read the detailed description
This is a single-center, prospective study in non-diabetic patients with acute coronary syndrome (ACS) (ST elevation (STEMI) or non-ST elevation (NSTEMI) with left ventricular systolic dysfunction (Defined as Ejection Fraction<50% assessed by 2D Simson Bi-plane echocardiography) or evidence of acute de Novo heart failure. The study will assess the effect of dapagliflozin or empagliflozin versus placebo, administered once daily in addition to standard therapy, on HF hospitalizations, all-cause deaths and ACS readmissions.
- Conditions
- Acute Coronary Syndromes, Heart Failure
- Being tested
- With ISGLT2
- Keywords
- Acute coronary syndronme, ISGLT2, Heart failure
- Medical subject headings
- Acute Coronary Syndrome, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
With ISGLT2Drug
Patients for whom we will prescribe ISGLT2
| Study group | Role | What they receive |
|---|---|---|
| Without ISGLT2 | Patients for whom we will not prescribe ISGLT2 Receives: Drug: With ISGLT2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoints
Time to the first occurrence of any of the components of this composite: hospitalization for heart failure (HHF), Non fatal Myocardial infarction (MI) or Death from all causes
Measured: 50 months
Secondary outcomes (1)
Secondary outcomes
Time to the first occurrence of a fatal or a non-fatal MI [Time Frame: From admission visit (Day 0) up to approximately 4.2years] Time to first hospitalisation for Heat failure [Time Frame: From admission visit (Day 0) up to approximately 3 years] Time to death of any cause [Time Frame: From admission visit (Day 0) up to approximately 4.2 years] Time to new onset of type 2 diabetes mellitus (T2DM) post discharge [Time Frame: From admission (Day 0) up to approximately 4.2 years] Time to new onset atrial fibrilation (AF) post discharge [Time Frame: From admission visit (Day 0) up to approximately 4.2 years]
Measured: 50 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start1 Oct 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohammed VI University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BOUCHLARHEM AMINE, Mohammed VI University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903754
- Sponsor's protocol ID
- DI657483
- Acronym
- ISGTL2-MORMI
- Status last verified
- Mar 2025
- First submitted
- 22 Mar 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium Glucose Cotransporter 2 Inhibitors in Patients Without Diabetes With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT06903754
- Acronym / sponsor ID
- ISGTL2-MORMI / DI657483
- Conditions
- Acute Coronary Syndromes, Heart Failure
- Keywords
- Acute coronary syndronme, ISGLT2, Heart failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Mohammed VI University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 1 Apr 2025 (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 will evaluate the effect of ISGLT2 (Dapagliflozin or Empalgliflozin), administered once daily in addition to standard of care treatments for non-diabetic patients with myocardial infarction (MI) treated with PCI, on hospitalization for heart failure, readmissions for acute coronary syndrome and all-cause mortality.
Detailed description
This is a single-center, prospective study in non-diabetic patients with acute coronary syndrome (ACS) (ST elevation (STEMI) or non-ST elevation (NSTEMI) with left ventricular systolic dysfunction (Defined as Ejection Fraction<50% assessed by 2D Simson Bi-plane echocardiography) or evidence of acute de Novo heart failure. The study will assess the effect of dapagliflozin or empagliflozin versus placebo, administered once daily in addition to standard therapy, on HF hospitalizations, all-cause deaths and ACS readmissions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Without ISGLT2 | – | Drug: With ISGLT2Patients for whom we will not prescribe ISGLT2 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with Acute coronary syndrome
Key inclusion criteria (4 listed)
- Participant must approved the informed consent.
- Confirmed MI, either STEMI or NSTEMI, according to the fourth universal definition of MI (Thygesen et al 2019).
- Evidence of impaired regional or global LV systolic function at any timepoint during current MI-related hospitalisation with Ejection Fraction<50%(established with echocardiogram, radionuclide ventriculogram, contrast angiography or cardiac MRI) or Symptoms of Acute heart failure without cardiogenic Shock.
- Hemodynamically stable (no episodes of symptomatic hypotension, or arrhythmia with haemodynamic compromise in the last 24 hours).
Key exclusion criteria (8 listed)
- Known type 1 diabetes mellitus (T1DM) or T2DM at the time for admission.
- Chronic symptomatic HF with a prior HHF within the last year and known reduced ejection fraction (LVEF≤40 %), documented before the current MI hospitalization.
- Patients with cardiogenic shock who received vasoactive drugs during index.
- Hospitalization Severe (eGFR <20 mL/min/1.73 m2 by local laboratory), unstable or rapidly progressing renal disease at the time of randomization
- Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into the trial.
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 |
|---|---|---|
| With ISGLT2Patients for whom we will prescribe ISGLT2 | Drug | Without ISGLT2 |
Primary outcome
Primary endpoints
Time frame: 50 months
Time to the first occurrence of any of the components of this composite: hospitalization for heart failure (HHF), Non fatal Myocardial infarction (MI) or Death from all causes
1 secondary outcome
Secondary outcomes
Time frame: 50 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndromes and Heart Failure, run by Mohammed VI University Hospital at 1 site in Morocco.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 15 Sep 2025. 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 Morocco. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoints (time frame: 50 months). 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 15 Sep 2025; AzTrials last refreshed its copy on 1 Nov 2026.