Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT05764057
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years;
* STEMI (e.g., ST elevation above the J-point of ≥0.1 millivolt in ≥two contiguous leads or left bundle branch block) or very high-risk NSTEMI (e.g., dynamic ECG changes or ongoing chest pain or acute heart failure or hemodynamic instability independent of ECG changes or life-threatening ventricular arrhythmias) with LV dysfunction (LVEF ≤45%); after completion of PCI or angiography procedure
* eGFR ≥ 25 mL/Min per 1.73m²;
* Systolic blood pressure (SBP) before first dosing \>100 mmHg and/or Diastolic blood pressure (DBP) \>70 mmHg before first dosing;
* Ability to provide written informed consent and willing to participate in the 6-month follow-up period.
* Affiliation to a national health care system (AME are not allowed).
Exclusion Criteria:
* Cardiogenic shock (SBP \<90 mmHg with clinical signs of low output or patients requiring inotropic agents) at randomization;
* Referred to surgery for coronary artery bypass grafting (CABG) or treatment of acute complications (e.g. ventricular septal rupture);
* Any other form of diabetes than diabetes type 2
* History of diabetic ketoacidosis (DKA); Known contra-indication to SGLT-2 inhibitors (hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption);
* \>1 episode of severe hypoglycemia within the last 6 months under treatment with insulin or sulfonylurea;
* Acute symptomatic urinary tract infection (UTI) or genital infection at the time of randomization;
* Concomitant treatment (and/or within the 4 weeks prior to the baseline visit) with any SGLT-2 inhibitor (dapagliflozin, canagliflozin, empagliflozin)
* Echocardiographic examination of insufficient quality to permit adequate analysis of the study end-points.
* Impossibility to evaluate cardiac remodeling using TTE (e.g., pacemaker or defibrillator …);
* Atrial fibrillation rhythm at randomization;
* Life expectancy \<6 month;
* Known pregnancy at time of randomization;
* Breastfeeding women
* Females of childbearing potential without adequate contraceptive methods (i.e. sterilization, intrauterine device, vasectomized partner; or medical history of hysterectomy)
* Current participation in another interventional trial. Patients under guardianship or curatorship
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05764057
Study Brief:
Protocol Section:
NCT05764057