protocolSection identificationModule nctId: NCT06286878, orgStudyIdInfo id: SDC 4620/17/120, briefTitle: Pleiotropic Effects of Dapagliflozin in Patients With Acute Coronary Syndromes, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-12-08, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2025-07-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: University of Sao Paulo, class: OTHER, descriptionModule 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., conditionsModule conditions: Myocardial Infarction, conditions: Acute Coronary Syndrome, conditions: Diabetes, conditions: Ventricular Dysfunction, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Single-center, prospective, randomized, double-blind, placebo-controlled clinical study., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Placebo, interventions name: Dapagliflozin, outcomesModule primaryOutcomes measure: Platelet aggregation using ADP, secondaryOutcomes measure: Platelet aggregation using ADP at 30 (± 5) days after study therapy, secondaryOutcomes measure: Platelet aggregation using ASPI at 30 (± 5) days after study therapy, otherOutcomes measure: Analyze the primary objective of the study in the following pre-specified subgroups:, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations 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, contacts name: José Carlos Nicolau, role: CONTACT, phone: 551126615058, email: josecarlosnicolau@gmail.com, geoPoint lat: -23.5475, lon: -46.63611, hasResults: False