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Medically Ill hospitalized Patients for COVID-19 THrombosis Extended ProphyLaxis with rivaroxaban ThErapy: Rationale and Design of the MICHELLE Trial.
Ramacciotti, Eduardo; Agati, Leandro Barile; Calderaro, Daniela; Volpiani, Giuliano Giova; de Oliveira, Caroline Candida Carvalho; Aguiar, Valéria Cristina Resende; Rodrigues, Elizabeth; Sobreira, Marcone Lima; Joviliano, Edwaldo Edner; Dusilek, Cesar; Itinose, Kenji; Dedivitis, Rogério Aparecido; Cortina, André Sementilli; Sanches, Suzanna Maria Viana; de Moraes, Nara Franzin; Tierno, Paulo Fernando Guimarães Morando Marzocchi; de Oliveira, André Luiz Malavasi Longo; Tachibana, Adriano; Chate, Rodrigo Caruso; Santos, Marcus Vinícius Barbosa; Cavalcante, Bruno Bezerra de Menezes; Moreira, Ricardo Cesar Rocha; Chiann, Chang; Tafur, Alfonso; Spyropoulos, Alex C; Lopes, Renato D.
  • Ramacciotti E; Science Valley Research Institute, Santo André, São Paulo, Brazil; Hospital e Maternidade Christóvão da Gama, Grupo Leforte, Santo André, São Paulo, Brazil. Electronic address: eduardoramacciotti@gmail.com.
  • Agati LB; Science Valley Research Institute, Santo André, São Paulo, Brazil.
  • Calderaro D; Interdisciplinary Medicine in Cardiology Unit Heart Institute (InCor)- University of São Paulo Medical School, São Paulo, Brazil.
  • Volpiani GG; Science Valley Research Institute, Santo André, São Paulo, Brazil; Hospital e Maternidade Christóvão da Gama, Grupo Leforte, Santo André, São Paulo, Brazil.
  • de Oliveira CCC; Science Valley Research Institute, Santo André, São Paulo, Brazil; Hospital e Maternidade Christóvão da Gama, Grupo Leforte, Santo André, São Paulo, Brazil.
  • Aguiar VCR; Science Valley Research Institute, Santo André, São Paulo, Brazil; Hospital e Maternidade Christóvão da Gama, Grupo Leforte, Santo André, São Paulo, Brazil.
  • Rodrigues E; Science Valley Research Institute, Santo André, São Paulo, Brazil.
  • Sobreira ML; Universidade Estadual Paulista (UNESP), Botucatu, Brazil.
  • Joviliano EE; Hospital das Clínicas de Ribeirão Preto, São Paulo University Medical School (USP), Ribeirão Preto, São Paulo, Brazil.
  • Dusilek C; Hospital do Rocio, Campo Largo, Paraná, Brazil.
  • Itinose K; Hospital do Rocio, Campo Largo, Paraná, Brazil.
  • Dedivitis RA; Irmandade da Santa Casa da Misericórdia de Santos, São Paulo, Brazil.
  • Cortina AS; Irmandade da Santa Casa da Misericórdia de Santos, São Paulo, Brazil.
  • Sanches SMV; Hospital Ana Neri, Salvador, Bahia, Brazil.
  • de Moraes NF; Hospital Municipal de Barueri, São Paulo, Brazil.
  • Tierno PFGMM; Hospital Municipal de Barueri, São Paulo, Brazil.
  • de Oliveira ALML; São Paulo State Public Women's Health Reference Center, São Paulo, Brazil.
  • Tachibana A; Hospital Israelita Albert Einstein, São Paulo, S.P., Brazil.
  • Chate RC; Hospital Israelita Albert Einstein, São Paulo, S.P., Brazil.
  • Santos MVB; Heart Institute (InCor)- University of São Paulo Medical School, São Paulo, Brazil.
  • Cavalcante BBM; Institute of Teaching and Research Hapvida, Fortaleza, CE, Brazil.
  • Moreira RCR; Hospital Nossa Senhora das Graças, Curitiba, Brazil.
  • Chiann C; Department of Statistics, Institute of Mathematics and Statistics, University of Sao Paulo, São Paulo, Brazil.
  • Tafur A; Northshore University Health System, Chicago, IL.
  • Spyropoulos AC; Zucker School of Medicine at Hofstra/Northwell and the Feinstein Institutes for Medical Research, Manhasset, NY.
  • Lopes RD; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.
Am Heart J ; 242: 115-122, 2021 12.
Article in English | MEDLINE | ID: covidwho-1392113
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.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Thrombosis / Factor Xa Inhibitors / Rivaroxaban / COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Long Covid Limits: Adult / Female / Humans / Male Country/Region as subject: South America / Brazil Language: English Journal: Am Heart J Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Thrombosis / Factor Xa Inhibitors / Rivaroxaban / COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Long Covid Limits: Adult / Female / Humans / Male Country/Region as subject: South America / Brazil Language: English Journal: Am Heart J Year: 2021 Document Type: Article