DAPAgliflozine to Attenuate Cardiac RemOdeling afTEr aCuTe myOcardial Infarction
Sponsored by Assistance Publique - Hôpitaux de Paris
About this trial
Last updated 2 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Started 2 years ago
What is this trial about?
What are the Participation Requirements?
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 ≥30 mL/Min per 1.73m²;
- Systolic blood pressure (SBP) before first dosing >110 mmHg;
- Diastolic blood pressure (DBP) before first dosing >70 mmHg;
- 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:
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);
- Blood pH <7.32;
- ; 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