DAPAgliflozine to Attenuate Cardiac RemOdeling afTEr aCuTe myOcardial Infarction
NCT ID: NCT05764057
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
450 participants
INTERVENTIONAL
2023-06-12
2026-10-12
Brief Summary
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Preventing cardiac remodeling, an established predictor of subsequent heart failure (HF) and cardiovascular death, is likely to translate into benefit in reducing clinical events in post-MI patients.
Detailed Description
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Patients with confirmed AMI (e.g., STEMI or very high-risk NSTEMI) with LV dysfunction (LVEF≤45%) after completion of percutaneous coronary intervention (PCI) will be assessed for eligibility. Patients will be randomized (in a 1:1 ratio) to receive dapagliflozin (10mg once day) or placebo for 6 months, on top of standard of care as recommended in current guidelines. Treatment will be prescribed as soon as possible after admission The first TTE (TTE-1) will be performed to confirm inclusion criteria (LVEF≤45%). Four visits are scheduled: at baseline and randomization (Visit D0), at discharge from the CICU (Visit 2) at Month 3 ±2 weeks (Visit 3), and at Month 6 (+ 4 weeks) (Visit 4). After randomization, Visit 2 and Visit 3 will be scheduled to check the tolerance of the drug. In addition, a phone call will be done to the patient to make sure he's not taking any Dapagliflozin (or equivalent as Empagliflozin) in addition to experimental treatment. Finally, the last visit (Visit 4) will be scheduled to collect clinical follow-up and to perform a TTE (TTE-2). Efficacy criteria will be assessed from randomization to Month 6 by TTE. All TTE results will be anonymized and centralized at a Corelab with assessment by independent cardiologists unaware of the patient treatment group.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dapagliflozin 10mg daily + standard of care
Dapagliflozin 10mg per day will be administered orally, as in clinical practice
Dapagliflozin propanediol (FORXIGA™/FARXIGA™1)
Dapagliflozin (10 mg per day; per os) on top of standard of care as recommended in current guidelines\* for 6 months (experimental group)
\*All patients will receive optimal medical therapy (including antithrombotic, beta-blockers, statins, angiotensin converting enzyme inhibitors or angiotensin receptor blocker or sacubitril/valsartan, diuretics, antagonists of the mineralocorticoid receptor) according to their clinical condition as recommended.
Placebo + standard of care
Placebo will be administered orally
Placebo comparator
Placebo daily on top of standard of care as recommended in current guidelines\* for 6 months (control group)
\*All patients will receive optimal medical therapy (including antithrombotic, beta-blockers, statins, angiotensin converting enzyme inhibitors or angiotensin receptor blocker or sacubitril/valsartan, diuretics, antagonists of the mineralocorticoid receptor) according to their clinical condition as recommended.
Interventions
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Dapagliflozin propanediol (FORXIGA™/FARXIGA™1)
Dapagliflozin (10 mg per day; per os) on top of standard of care as recommended in current guidelines\* for 6 months (experimental group)
\*All patients will receive optimal medical therapy (including antithrombotic, beta-blockers, statins, angiotensin converting enzyme inhibitors or angiotensin receptor blocker or sacubitril/valsartan, diuretics, antagonists of the mineralocorticoid receptor) according to their clinical condition as recommended.
Placebo comparator
Placebo daily on top of standard of care as recommended in current guidelines\* for 6 months (control group)
\*All patients will receive optimal medical therapy (including antithrombotic, beta-blockers, statins, angiotensin converting enzyme inhibitors or angiotensin receptor blocker or sacubitril/valsartan, diuretics, antagonists of the mineralocorticoid receptor) according to their clinical condition as recommended.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Etienne PUYMIRAT, Pr
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Department of Cardiology AP-HP Hôpital européen Georges - Pompidou
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Etienne PUYMIRAT
Role: primary
Other Identifiers
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2022-001901-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AOM20806
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
APHP211054
Identifier Type: -
Identifier Source: org_study_id