Last updated: April 3, 2024
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting
Phase
3
Condition
Occlusions
Heart Failure
Circulation Disorders
Treatment
Dapagliflozin propanediol (FORXIGA™/FARXIGA™1)
Placebo comparator
Clinical Study ID
NCT05764057
APHP211054
AOM20806
2022-001901-28
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age ≥18 years;
- STEMI (e.g., ST elevation above the J-point of ≥0.1 millivolt in ≥two contiguous leadsor left bundle branch block) or very high-risk NSTEMI (e.g., dynamic ECG changes orongoing chest pain or acute heart failure or hemodynamic instability independent ofECG 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 bloodpressure (DBP) >70 mmHg before first dosing;
- Ability to provide written informed consent and willing to participate in the 6-monthfollow-up period.
- Affiliation to a national health care system (AME are not allowed).
Exclusion
Exclusion Criteria:
- Cardiogenic shock (SBP <90 mmHg with clinical signs of low output or patientsrequiring inotropic agents) at randomization;
- Referred to surgery for coronary artery bypass grafting (CABG) or treatment of acutecomplications (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 orglucose-galactose malabsorption);
- >1 episode of severe hypoglycemia within the last 6 months under treatment withinsulin or sulfonylurea;
- Acute symptomatic urinary tract infection (UTI) or genital infection at the time ofrandomization;
- Concomitant treatment (and/or within the 4 weeks prior to the baseline visit) with anySGLT-2 inhibitor (dapagliflozin, canagliflozin, empagliflozin)
- Echocardiographic examination of insufficient quality to permit adequate analysis ofthe study end-points.
- Impossibility to evaluate cardiac remodeling using TTE (e.g., pacemaker ordefibrillator …);
- 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 ofhysterectomy)
- Current participation in another interventional trial. Patients under guardianship orcuratorship
Study Design
Total Participants: 450
Treatment Group(s): 2
Primary Treatment: Dapagliflozin propanediol (FORXIGA™/FARXIGA™1)
Phase: 3
Study Start date:
June 12, 2023
Estimated Completion Date:
January 09, 2026
Study Description
Connect with a study center
Department of Cardiology AP-HP Hôpital européen Georges - Pompidou
Paris, 75015
FranceActive - Recruiting
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