[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571469":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":25,"responsibleParty":40,"collaborators":44,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":25,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":25,"enrollmentInfo":56,"targetDuration":25,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":69,"whyStopped":25,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":25},{"fullName":5,"class":6},"University of Sao Paulo","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"IPE Supplementation Group","ACTIVE_COMPARATOR","Dietary Supplement: Icosapent Ethy capsules",[13],"Dietary Supplement: Icosapent-ethyl ester capsules",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Group","PLACEBO_COMPARATOR","Dietary Supplement: Corn oil Control",[17],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","Icosapent-ethyl ester capsules","Icosapent-ethyl ester (4.0 g of EPA) taken twice a day (2.0 g\u002Fday x 2) for six months.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Corn oil Control","Corn oil twice a day (2.0 g\u002Fday x 2) for six months.",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Inar Castro Inar Castro Erger, Professor","CONTACT","+55(11)97429-3369","inar@usp.br",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Vivian Moura Doctor Student, Master","+55(11)96645-2370","vivianmoura@usp.br",{"type":41,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Inar Castro Erger","Professor",[45],{"name":46,"class":6},"InCor Heart Institute","100571469","effect-of-icosapent-ethyl-ester-ipe-to-reduce-the-residual-risk-cardiovascular-disease-100571469",false,"NCT06720662","Effect of Icosapent-ethyl Ester (IPE) to Reduce the Residual Risk Cardiovascular Disease.","Effect of Icosapent-ethyl Ester (IPE) to Reduce the Residual Risk in Patients Undergoing Secondary Prevention for Cardiovascular Disease.","Inclusion Criteria: individuals from both sexes, aging 45 years or older having established CVD, without contraindications to the use of IPE, receiving a stable dose of a statin (± ezetimibe) for ≥4 weeks. Women should be not pregnant, not breastfeeding, not planning on becoming pregnant, and using an acceptable form of birth control during the study (if of child-bearing potential). Biomarkers should be:\n\nhsCRP level - mg\u002Fliter: from 1 to 4.5; Triglyceride level - mg\u002Fdl: from 150 - 500; HDL cholesterol level - mg\u002Fdl: from 30 - 50 and LDL cholesterol level - mg\u002Fdl: from 40 - 100.\n\nExclusion Criteria: Patients with severe heart failure, active severe liver disease, a glycated hemoglobin level greater than 10.0%, a planned coronary intervention or surgery, a history of acute or chronic pancreatitis, or known hypersensitivity to fish, shellfish, or ingredients of icosapent ethyl or placebo. Autoimmune disease requiring the use of immunosuppressive therapy or current use of systemic corticosteroid therapy; Active neoplasm with indication for surgery, chemotherapy or radiation in the last 12 months (patients with a history of neoplasia and who have undergone curative surgery without the need for treatment in the last 12 months will be allowed); Inflammatory bowel disease or chronic diarrhea; Clinically significant non-transient hematological abnormalities; Renal dysfunction (GFR \\\u003C 30 mL\u002Fmin\u002F1.73 m² and\u002For serum creatinine \\> 2.5 mg\u002FdL or \\\u003C 220 μmol\u002Fl); Severe liver disease (aspartate aminotransferase \\[AST\\] or alanine aminotransferase \\[ALT\\] \\> 3x ULN in the last 6 months); Inability to sign the free and informed consent form; Participation in another clinical trial involving an investigational agent within 90 days prior to screening; Intolerance or hypersensitivity to statin therapy; History of acute or chronic pancreatitis; Malabsorption syndrome and\u002For chronic diarrhea; Use of non-study drug-related, non-statin, lipid-altering medications, dietary supplements, Niacin (\\>200 mg\u002Fd) or fibrates (unless ≥28-day washout). Any n-3 fatty acid medications (unless ≥28-day washout). Bile acid sequestrants (unless ≥7-day washout), PCSK9 inhibitors (unless ≥90-day washout); Other medications (not indicated for lipid alteration): Tamoxifen, estrogens, progestins, thyroid hormone therapy, systemic corticosteroids (local, topical, inhalation, or nasal corticosteroids are allowed), HIV-protease inhibitors that have not been stable for ≥28 days prior to the qualifying lipid measurements (TG and LDL-C) during screening. Cyclophosphamide or systemic retinoids during the screening period (unless ≥28- day washout) and\u002For plans for use during the treatment\u002Ffollow-up period ; HIV-positive patients even without AIDS; Requirement for peritoneal dialysis or hemodialysis for renal insufficiency or creatinine clearance 5 × ULN or elevation due to known muscle disease; Drug or alcohol abuse within the past 6 months, and inability\u002Funwillingness to abstain from drug abuse and excessive alcohol consumption during the study; 16 Mental\u002Fpsychological impairment or any other reason to expect patient difficulty in complying with the requirements of the study or understanding the goal and potential risks of participating in the study.\n\nPatients with Atrial fibrillation and Bleeding related disorders.\n\n\\-","ALL","45 Years",{"count":57,"type":58},294,"ESTIMATED","INTERVENTIONAL",[61],"NA","Cardiovascular diseases (CVDs) are the leading cause of global mortality, despite significant advances in prevention and treatment. Atherosclerosis, a chronic inflammatory condition, underlies ischemic events such as infarction and stroke, triggered by the instability and rupture of plaques. Current guidelines recommend drugs primarily aimed at reducing Low-Density-Lipoprotein cholesterol (LDL-C), arterial pressure, and glucose levels for atherosclerosis patients. However, there is little option of approved medications specifically targeting inflammation within the arterial plaques. Consequently, a significant proportion of patients face residual risks. On the contrary, numerous studies have highlighted the anti-inflammatory effects provided by omega-3 fatty acids (n-3 FA), specially the eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and their derived oxylipins. These molecules exhibit the ability to enhance the phenotype of macrophages, increasing their capacity for efferocytosis, thereby improving plaque stability. Icosapent ethyl (IPE) is an esterifed version of eicosapentaenoic acid (EPA) and acts as a prodrug in the body to exert its effects. Icosapent ethyl (IPE) was the first fish oil product approved by the US Food and Drug Administration (FDA) to reduce the risk of atherosclerotic cardiovascular disease (ASCVD) in adults. Hence, the hypothesis of this study is that supplementing patients with IPE, in addition to their standard clinical treatment, will enhance macrophage functionality, thereby reducing inflammatory and oxidative stress biomarkers in comparison to a placebo. To test this hypothesis,a Randomized, Double-blind, Placebo-controlled Clinical trial will be performed, in which 294 patients under secondary prevention for CVDs will receive a 6-month supplementation of purified eicosapentaenoic acid-icosapent ethyl (4.0 g) daily or a Placebo (corn oil). Blood samples and anthropometric measurements will be taken at the beginning and end of the period. Basic clinical markers will be assessed, and monocytes will be collected and characterized. Fatty acid profiles and oxylipins will be determined through chromatography coupled with mass spectrometry. Finally, changes in biomarkers for both groups will undergo multivariate analysis to identify characteristics associated with the response to supplementation. Data from this study aims to provide support for physicians considering the prescription of bioactive compounds as a complementary therapy for atherosclerosis, with the goal of reducing residual risks and subsequently decreasing mortality resulting from cardiovascular events.",[64],"Atherosclerosis Cardiovascular Disease",[66,67,68],"omega 3 fatty acids","atherosclerosis","oxylipins","NOT_YET_RECRUITING","2024-12-09",{"date":72,"type":73},"2024-12-13","ACTUAL",{"date":75,"type":58},"2025-04-01",{"date":77,"type":58},"2026-01-30",{"name":5,"class":6}]