Medically Ill hospitalized Patients for COVID-19 THrombosis Extended ProphyLaxis with rivaroxaban ThErapy: Rationale and Design of the MICHELLE Trial - 30/10/21
, Leandro Barile Agati, PhD a, Daniela Calderaro, MD, PhD c, Giuliano Giova Volpiani, MD a, b, Caroline Candida Carvalho de Oliveira, MD a, b, Valéria Cristina Resende Aguiar, MD a, b, Elizabeth Rodrigues, PhD a, Marcone Lima Sobreira, MD, PhD d, Edwaldo Edner Joviliano, MD, PhD e, Cesar Dusilek, MD f, Kenji Itinose, MD f, Rogério Aparecido Dedivitis, MD, PhD g, André Sementilli Cortina, MD g, Suzanna Maria Viana Sanches, MD h, Nara Franzin de Moraes, MD i, Paulo Fernando Guimarães Morando Marzocchi Tierno, MD i, André Luiz Malavasi Longo de Oliveira, MD j, Adriano Tachibana, MD, PhD k, Rodrigo Caruso Chate, MD, PhD k, Marcus Vinícius Barbosa Santos, MD l, Bruno Bezerra de Menezes Cavalcante, MD m, Ricardo Cesar Rocha Moreira, MD n, Chang Chiann, PhD o, Alfonso Tafur, MD p, Alex C. Spyropoulos, MD q, Renato D. Lopes, MD, PhD r
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Riassunto |
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
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| # | This paper is not under consideration for publication elsewhere, and its publication is approved by all authors. |
Vol 242
P. 115-122 - Dicembre 2021 Ritorno al numero
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