Effects of Dapagliflozin on Heart Health in Patients with Acute Coronary Syndromes

Pleiotropic Effects of Dapagliflozin in Patients With Acute Coronary Syndromes

This study is testing if dapagliflozin, a diabetes medication, can improve heart health in people who have just had a heart attack.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Sao Paulo (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (São Paulo, São Paulo)
• Trial ID: NCT06286878 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the potential benefits of dapagliflozin, a medication typically used for type 2 diabetes, in patients who have experienced an acute myocardial infarction. The study is designed as a prospective, randomized, double-blind, placebo-controlled trial, where participants will receive either dapagliflozin or a placebo within seven days of their heart attack. The primary focus is to assess platelet aggregation and other cardiovascular biomarkers to determine if dapagliflozin has effects beyond glycemic control. Additional exploratory analyses will investigate various cardiac and metabolic parameters over a specified follow-up period.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who have been diagnosed with acute myocardial infarction and are receiving dual antiplatelet therapy.

Not a fit: Patients currently using SGLT2 inhibitors or certain other medications that may interfere with the study's outcomes may not benefit from this trial.

Why it matters

Potential benefit: If successful, this study could provide new insights into the cardiovascular benefits of dapagliflozin, potentially improving outcomes for patients with acute coronary syndromes.

How similar studies have performed: While the specific pleiotropic effects of dapagliflozin in this context are novel, other studies have indicated potential cardiovascular benefits of SGLT2 inhibitors in similar patient populations.

Eligibility criteria

Inclusion 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 symptoms;
* Signature of the Free and Informed Consent Term.

Exclusion criteria:

* 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 recurrent ventricular arrhythmias) or non cardiovascular (eg, active malignancy other than basal cell carcinoma, cirrhosis, chronic lung disease, severe autoimmune disease);
* 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 \<150,000/mm³ or \> 450,000/mm³)

Where this trial is running

São Paulo, São Paulo

• Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo — São Paulo, São Paulo, Brazil (Recruiting)

Study contacts

• Study coordinator: Jose JN Nicolau

Conditions Myocardial Infarction; Acute Coronary Syndrome; Diabetes; Ventricular Dysfunction