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New treatment option for Myocardial Infarction
Official title Pleiotropic Effects of Dapagliflozin in Patients With Acute Coronary Syndromes
ClinicalTrials.gov ID: NCT06286878
What this study is testing
What is Dapagliflozin?
Dapagliflozin is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for myocardial infarction.
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
- Type 2 diabetes mellitus (T2DM) is one of the most important risk factors for atherosclerotic heart disease. Strategies focused solely on glycemic control have failed to demonstrate vascular events reduction in this population.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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
- Men and women aged ≥ 18 years (women of childbearing age must have a negative pregnancy test);
- In routine use of dual antiplatelet therapy with ASA plus an ADP receptor antagonist, according to institutional routines;
- Acute myocardial infarction, with or without ST-segment elevation (STEMI/NSTEMI) defined according to the 4th Universal Definition of Acute...
- Signature of the Free and Informed Consent Term.
You likely can't join if
- Current or recent (within 24 months) treatment with pioglitazone and/or use of pioglitazone for a total of 2 years or more during a lifetime at any...
- Current or recent (within 12 months) treatment with rosiglitazone;
- Chronic use (\>15 consecutive days) of any SGLT2 inhibitor at the time of hospitalization;
- Chronic use (\>30 consecutive days) with an oral steroid at a dose equivalent to prednisolone ≥10 mg (eg, betamethasone ≥1.2 mg, dexamethasone ≥1.5...
- Systolic BP \> 180 or diastolic BP \> 100 mmHg at randomization;
- Diagnosis of Type 1 diabetes mellitus, MODY (maturity onset diabetes of the Young) or diabetes mellitus secondary to diverse endocrinopathy...
See the full eligibility criteria
- Men and women aged ≥ 18 years (women of childbearing age must have a negative pregnancy test);
- In routine use of dual antiplatelet therapy with ASA plus an ADP receptor antagonist, according to institutional routines;
- Acute myocardial infarction, with or without ST-segment elevation (STEMI/NSTEMI) defined according to the 4th Universal Definition of Acute Myocardial Infarction, with up to 7 days of evolution from the onset of...
- Signature of the Free and Informed Consent Term.
- Current or recent (within 24 months) treatment with pioglitazone and/or use of pioglitazone for a total of 2 years or more during a lifetime at any time;
- Current or recent (within 12 months) treatment with rosiglitazone;
- Chronic use (\>15 consecutive days) of any SGLT2 inhibitor at the time of hospitalization;
- Chronic use (\>30 consecutive days) with an oral steroid at a dose equivalent to prednisolone ≥10 mg (eg, betamethasone ≥1.2 mg, dexamethasone ≥1.5 mg, hydrocortisone ≥40 mg) per day;
- Systolic BP \> 180 or diastolic BP \> 100 mmHg at randomization;
- Diagnosis of Type 1 diabetes mellitus, MODY (maturity onset diabetes of the Young) or diabetes mellitus secondary to diverse endocrinopathy, pancreatic resection, medication, pancreas neoplasia or chronic pancreatitis;
- History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time;
- History of any other malignancy within 5 years (with the exception of skin cancers successfully treated non-melanoma);
- Chronic cystitis and/or recurrent urinary tract infections (3 or more in the last year);
- Any condition that, in the opinion of the Investigator, may render the research participant unfit to complete the study, including, but not limited to, cardiovascular disease (KILLIP \> 2, modified Forester \> IIa,35...
- Pregnancy or lactation;
- Active participation in another clinical trial
- Patients with septic shock or severe glycemic decompensation requiring the use of IV insulin at the time of randomization;
- TGP/ALT(Alanine Amino Transferase) \>3x the upper limit of normality (ULN) or total bilirubin \>2.5 x ULN;
- Estimated glomerular filtration rate (GFR) \< 45 ml/min/1.73m² , calculated by MDRD, or kidney transplant;
- Known thrombophilias or thrombocytosis;
- Blood dyscrasias or any disorder that causes hemolysis, previously known;
- Hematological abnormality (Hb ≤ 11g/dL or \> 17g/dL, leukocytes ≤ 4500/mm³ or \>11000/mm³, platelet count \ 450,000/mm³)
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, São Paulo, Brazil
Compensation & support
Compensation likely.
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 São Paulo, São Paulo, Brazil. 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.