nctId: NCT06286878 id: SDC 4620/17/120 briefTitle: Pleiotropic Effects of Dapagliflozin in Patients With Acute Coronary Syndromes overallStatus: RECRUITING date: 2021-12-08 date: 2024-12-30 date: 2025-07-30 date: 2024-02-29 date: 2024-02-29 name: University of Sao Paulo class: OTHER briefSummary: 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. conditions: Myocardial Infarction conditions: Acute Coronary Syndrome conditions: Diabetes conditions: Ventricular Dysfunction studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Single-center, prospective, randomized, double-blind, placebo-controlled clinical study. primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: Placebo name: Dapagliflozin measure: Platelet aggregation using ADP measure: Platelet aggregation using ADP at 30 (± 5) days after study therapy measure: Platelet aggregation using ASPI at 30 (± 5) days after study therapy measure: Analyze the primary objective of the study in the following pre-specified subgroups: sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo status: RECRUITING city: Sao Paulo zip: 05403-900 country: Brazil name: José Carlos Nicolau role: CONTACT phone: 551126615058 email: josecarlosnicolau@gmail.com lat: -23.5475 lon: -46.63611 hasResults: False