Medically Ill hospitalized Patients for COVID-19 THrombosis Extended ProphyLaxis with rivaroxaban ThErapy: Rationale and Design of the MICHELLE Trial

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Autor(es): dc.contributorScience Valley Research Institute-
Autor(es): dc.contributorUniversidade de São Paulo (USP)-
Autor(es): dc.contributorUniversidade Estadual Paulista (UNESP)-
Autor(es): dc.contributorIrmandade da Santa Casa da Misericórdia de Santos-
Autor(es): dc.contributorHospital Ana Neri-
Autor(es): dc.contributorHospital Municipal de Barueri-
Autor(es): dc.contributorSão Paulo State Public Women's Health Reference Center-
Autor(es): dc.contributorHospital Israelita Albert Einstein-
Autor(es): dc.contributorCE-
Autor(es): dc.contributorHospital Nossa Senhora das Graças-
Autor(es): dc.contributorNorthshore University Health System-
Autor(es): dc.contributorDuke University School of Medicine-
Autor(es): dc.creatorRamacciotti, Eduardo-
Autor(es): dc.creatorAgati, Leandro Barile-
Autor(es): dc.creatorCalderaro, Daniela-
Autor(es): dc.creatorVolpiani, Giuliano Giova-
Autor(es): dc.creatorde Oliveira, Caroline Candida Carvalho-
Autor(es): dc.creatorAguiar, Valéria Cristina Resende-
Autor(es): dc.creatorRodrigues, Elizabeth-
Autor(es): dc.creatorSobreira, Marcone Lima-
Autor(es): dc.creatorJoviliano, Edwaldo Edner-
Autor(es): dc.creatorDusilek, Cesar-
Autor(es): dc.creatorItinose, Kenji-
Autor(es): dc.creatorDedivitis, Rogério Aparecido-
Autor(es): dc.creatorCortina, André Sementilli-
Autor(es): dc.creatorSanches, Suzanna Maria Viana-
Autor(es): dc.creatorde Moraes, Nara Franzin-
Autor(es): dc.creatorTierno, Paulo Fernando Guimarães Morando Marzocchi-
Autor(es): dc.creatorde Oliveira, André Luiz Malavasi Longo-
Autor(es): dc.creatorTachibana, Adriano-
Autor(es): dc.creatorChate, Rodrigo Caruso-
Autor(es): dc.creatorSantos, Marcus Vinícius Barbosa-
Autor(es): dc.creatorCavalcante, Bruno Bezerra de Menezes-
Autor(es): dc.creatorMoreira, Ricardo Cesar Rocha-
Autor(es): dc.creatorChiann, Chang-
Autor(es): dc.creatorTafur, Alfonso-
Autor(es): dc.creatorSpyropoulos, Alex C.-
Autor(es): dc.creatorLopes, Renato D.-
Data de aceite: dc.date.accessioned2025-08-21T19:41:27Z-
Data de disponibilização: dc.date.available2025-08-21T19:41:27Z-
Data de envio: dc.date.issued2022-04-29-
Data de envio: dc.date.issued2022-04-29-
Data de envio: dc.date.issued2021-11-30-
Fonte completa do material: dc.identifierhttp://dx.doi.org/10.1016/j.ahj.2021.08.016-
Fonte completa do material: dc.identifierhttp://hdl.handle.net/11449/231568-
Fonte: dc.identifier.urihttp://educapes.capes.gov.br/handle/11449/231568-
Descrição: dc.descriptionBACKGROUND: The devastating Coronavirus disease (COVID-19) pandemic is associated with a high prothrombotic state. It is unclear if the coagulation abnormalities occur because of the direct effect of SARS-CoV-2 or indirectly by the cytokine storm and endothelial damage or by a combination of mechanisms. There is a clear indication of in-hospital pharmacological thromboprophylaxis for every patient with COVID-19 after bleed risk assessment. However, there is much debate regarding the best dosage regimen, and there is no consensus on the role of extended thromboprophylaxis. DESIGN: This study aims to evaluate the safety and efficacy of rivaroxaban 10 mg once daily for 35 ± 4 days versus no intervention after hospital discharge in COVID-19 patients who were at increased risk for VTE and have received standard parenteral VTE prophylaxis during hospitalization. The composite efficacy endpoint is a combination of symptomatic VTE, VTE-related death, VTE detected by bilateral lower limbs venous duplex scan and computed tomography pulmonary angiogram on day 35 ± 4 posthospital discharge and symptomatic arterial thromboembolism (myocardial infarction, nonhemorrhagic stroke, major adverse limb events, and cardiovascular death) up to day 35 ± 4 posthospital discharge. The key safety outcome is the incidence of major bleeding according to ISTH criteria. SUMMARY: The MICHELLE trial is expected to provide high-quality evidence around the role of extended thromboprophylaxis in COVID-19 and will help guide medical decisions in clinical practice.1.-
Descrição: dc.descriptionScience Valley Research Institute, Santo André, São Paulo, Brazil; Hospital e Maternidade Christóvão da Gama, Grupo Leforte, Santo André, São Paulo, Brazil-
Descrição: dc.descriptionScience Valley Research Institute-
Descrição: dc.descriptionInterdisciplinary Medicine in Cardiology Unit Heart Institute (InCor)- University of São Paulo Medical School-
Descrição: dc.descriptionUniversidade Estadual Paulista (UNESP)-
Descrição: dc.descriptionHospital das Clínicas de Ribeirão Preto São Paulo University Medical School (USP)-
Descrição: dc.descriptionIrmandade da Santa Casa da Misericórdia de Santos-
Descrição: dc.descriptionHospital Ana Neri-
Descrição: dc.descriptionHospital Municipal de Barueri-
Descrição: dc.descriptionSão Paulo State Public Women's Health Reference Center-
Descrição: dc.descriptionHospital Israelita Albert Einstein-
Descrição: dc.descriptionHeart Institute (InCor)- University of São Paulo Medical School-
Descrição: dc.descriptionInstitute of Teaching and Research Hapvida CE-
Descrição: dc.descriptionHospital Nossa Senhora das Graças-
Descrição: dc.descriptionDepartment of Statistics Institute of Mathematics and Statistics University of Sao Paulo-
Descrição: dc.descriptionNorthshore University Health System-
Descrição: dc.descriptionZucker School of Medicine at Hofstra/Northwell and the Feinstein Institutes for Medical Research, Manhasset, NY-
Descrição: dc.descriptionDuke Clinical Research Institute Duke University School of Medicine-
Descrição: dc.descriptionUniversidade Estadual Paulista (UNESP)-
Formato: dc.format115-122-
Idioma: dc.languageen-
Relação: dc.relationAmerican heart journal-
???dc.source???: dc.sourceScopus-
Título: dc.titleMedically Ill hospitalized Patients for COVID-19 THrombosis Extended ProphyLaxis with rivaroxaban ThErapy: Rationale and Design of the MICHELLE Trial-
Tipo de arquivo: dc.typelivro digital-
Aparece nas coleções:Repositório Institucional - Unesp

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