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RECRUITING

NCT06286878

PHASE2/PHASE3

Pleiotropic Effects of Dapagliflozin in Patients With Acute Coronary Syndromes

Sponsor: University of Sao Paulo

View on ClinicalTrials.gov

Summary

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. On the other hand, new antidiabetic drugs recently have demonstrated significant decrease of cardiovascular mortality, raising the hypothesis that possible effects beyond glycemia control could explain this benefit. Aim: This study is intended to evaluate possible pleiothropic effects of dapaglifozin, a SGLT-2 (sodium glucose cotransporter 2) inhibitor, in individuals admitted with a diagnosis of Acute Myocardial Infarction (AMI). Methods: This is a prospective, randomized, double-blind, placebo controlled trial. Individuals presenting with AMI whithin the first seven days of evolution will be randomized to dapaglifozin or placebo. The investigators's goal is to analyze platelet aggregability 48 hours after randomization (primary endpoint), as well as glycemic control, cardiac biomarkers, corrected QT interval electrocardiographic analysis, autonomic modulation through spectral analysis of the RR interval and inflammatory biomarkers at inclusion and 30 days after starting study drug (secondary endpoints). Sample size calculation resulted in 80 individuals (40 per group). Expected results: This study will seek to aggregate new insights to the current knowledge about this new antidiabetic drug class. Previous randomized clinical trials have demonstrated that SGLT-2 inhibitors significantly reduced the composite endpoint of cardiovascular death, AMI or stroke, as well as Heart Failure (HF) hospitalization. Therefore, this study is supposed to clarify possible mechanisms that could explain these results aforementioned.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2021-12-08

Completion Date

2025-07-30

Last Updated

2025-04-25

Healthy Volunteers

Conditions

Myocardial Infarction Acute Coronary Syndrome Diabetes Ventricular Dysfunction

Interventions

DRUG

Placebo

Patients will be randomized to use dapagliflozin or placebo in a double-blind way

DRUG

Dapagliflozin

Patients will be randomized to use dapagliflozin or placebo in a double-blind way

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)

Locations (1)

Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo

São Paulo, São Paulo, Brazil