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

Made available in DSpace on 2022-04-29T08:46:11Z (GMT). No. of bitstreams: 0 Previous issue date: 2021-12-01 BACKGROUND: 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. Science Valley Research Institute, Santo André, São Paulo, Brazil; Hospital e Maternidade Christóvão da Gama, Grupo Leforte, Santo André, São Paulo, Brazil Science Valley Research Institute Interdisciplinary Medicine in Cardiology Unit Heart Institute (InCor)- University of São Paulo Medical School Universidade Estadual Paulista (UNESP) Hospital das Clínicas de Ribeirão Preto São Paulo University Medical School (USP) Irmandade da Santa Casa da Misericórdia de Santos Hospital Ana Neri Hospital Municipal de Barueri São Paulo State Public Women's Health Reference Center Hospital Israelita Albert Einstein Heart Institute (InCor)- University of São Paulo Medical School Institute of Teaching and Research Hapvida CE Hospital Nossa Senhora das Graças Department of Statistics Institute of Mathematics and Statistics University of Sao Paulo Northshore University Health System Zucker School of Medicine at Hofstra/Northwell and the Feinstein Institutes for Medical Research, Manhasset, NY Duke Clinical Research Institute Duke University School of Medicine Universidade Estadual Paulista (UNESP)