Abstract
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 .
【초록키워드】 COVID-19, SARS-CoV-2, Efficacy, pandemic, Trial, Hospitalization, stroke, risk, Intervention, endothelial damage, outcome, discharge, Coagulation, Prophylaxis, Computed tomography, symptomatic, Thromboembolism, death, mechanisms, incidence, Myocardial infarction, disease, Clinical practice, Thromboprophylaxis, Evidence, Combination, COVID-19 patient, VTE, criteria, regimen, lower limb, In-hospital, Consensus, Endpoint, increased risk, dosage, hospital discharge, help, prothrombotic state, abnormality, major bleeding, pharmacological, patient with COVID-19, venous, limb, evaluate, events, occur, expected, the cytokine storm, 【제목키워드】 COVID-19, Hospitalized, rationale, Extended, Ill,