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New treatment option for AMI
Official title DAPAgliflozine to Attenuate Cardiac RemOdeling afTEr aCuTe myOcardial Infarction
ClinicalTrials.gov ID: NCT05764057
What this study is testing
What is Dapagliflozin propanediol (FORXIGA™/FARXIGA™1)?
Dapagliflozin propanediol (FORXIGA™/FARXIGA™1) is an investigational medicine, being studied as a potential treatment for ami.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Recent clinical trials have proven the cardiovascular benefits of new medications for patients with heart failure with reduced ejection fraction (HFrEF), especially sodium-glucose co-transporter 2 (SGLT2) inhibitors. There are no existing randomized clinical trials evaluating the efficacy and safety of dapagliflozin (nor any other SGLT2-inhibitor) to limit cardiac remodeling in patients with acute myocardial infarction (AMI) and left ventricular (LV) dysfunction.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- \>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;
See the full eligibility 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...
- 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).
- 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 treatment trial. Patients under guardianship or curatorship
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.