Pleiotropic Effects of Dapagliflozin in Patients With Acute Coronary Syndromes

Launched by UNIVERSITY OF SAO PAULO · Feb 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called dapagliflozin in patients who have recently experienced an acute heart attack, known as acute myocardial infarction (AMI). Researchers want to understand if this medication can provide benefits beyond just controlling blood sugar levels, especially for patients with type 2 diabetes, who are at higher risk for heart problems. Participants will be randomly assigned to receive either dapagliflozin or a placebo (a dummy treatment) and will be monitored for various health indicators over a period of 30 days.

To be eligible for the trial, participants must be at least 18 years old and have had a heart attack within the last week. They should also be receiving standard treatment for heart attacks, which includes certain medications to help prevent blood clots. However, there are several criteria that would exclude someone from participating, such as having specific medical conditions or recent treatments that could interfere with the study. If you choose to participate, you will be helping researchers gather important information that may improve treatment options for people with diabetes and heart disease in the future.

Gender

ALL

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)