tetano
Editor, Senior Moderator
Am Heart J
. 2021 Sep 1;S0002-8703(21)00222-2.
doi: 10.1016/j.ahj.2021.08.016. Online ahead of print.
Medically Ill hospitalized Patients for COVID-19 THrombosis Extended ProphyLaxis with rivaroxaban ThErapy: Rationale and Design of the MICHELLE Trial
Eduardo Ramacciotti[SUP] 1 [/SUP], Leandro Barile Agati[SUP] 2 [/SUP], Daniela Calderaro[SUP] 3 [/SUP], Giuliano Giova Volpiani[SUP] 4 [/SUP], Caroline Candida Carvalho de Oliveira[SUP] 4 [/SUP], Valéria Cristina Resende Aguiar[SUP] 4 [/SUP], Elizabeth Rodrigues[SUP] 2 [/SUP], Marcone Lima Sobreira[SUP] 5 [/SUP], Edwaldo Edner Joviliano[SUP] 6 [/SUP], Cesar Dusilek[SUP] 7 [/SUP], Kenji Itinose[SUP] 7 [/SUP], Rogério Aparecido Dedivitis[SUP] 8 [/SUP], André Sementilli Cortina[SUP] 8 [/SUP], Suzanna Maria Viana Sanches[SUP] 9 [/SUP], Nara Franzin de Moraes[SUP] 10 [/SUP], Paulo Fernando Guimarães Morando Marzocchi Tierno[SUP] 10 [/SUP], André Luiz Malavasi Longo de Oliveira[SUP] 11 [/SUP], Adriano Tachibana[SUP] 12 [/SUP], Rodrigo Caruso Chate[SUP] 12 [/SUP], Marcus Vinícius Barbosa Santos[SUP] 13 [/SUP], Bruno Bezerra de Menezes Cavalcante[SUP] 14 [/SUP], Ricardo Cesar Rocha Moreira[SUP] 15 [/SUP], Chang Chiann[SUP] 16 [/SUP], Alfonso Tafur[SUP] 17 [/SUP], Alex C Spyropoulos[SUP] 18 [/SUP], Renato D Lopes[SUP] 19 [/SUP]
Affiliations
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 post-hospital discharge and symptomatic arterial thromboembolism (myocardial infarction [MI], non-hemorrhagic stroke, major adverse limb events [MALE] and cardiovascular [CV] death) up to day 35±4 post-hospital 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.
Keywords: COVID-19; SARS-CoV-2; anticoagulation; direct oral anticoagulants; rivaroxaban; thrombosis; venous thromboembolism.
. 2021 Sep 1;S0002-8703(21)00222-2.
doi: 10.1016/j.ahj.2021.08.016. Online ahead of print.
Medically Ill hospitalized Patients for COVID-19 THrombosis Extended ProphyLaxis with rivaroxaban ThErapy: Rationale and Design of the MICHELLE Trial
Eduardo Ramacciotti[SUP] 1 [/SUP], Leandro Barile Agati[SUP] 2 [/SUP], Daniela Calderaro[SUP] 3 [/SUP], Giuliano Giova Volpiani[SUP] 4 [/SUP], Caroline Candida Carvalho de Oliveira[SUP] 4 [/SUP], Valéria Cristina Resende Aguiar[SUP] 4 [/SUP], Elizabeth Rodrigues[SUP] 2 [/SUP], Marcone Lima Sobreira[SUP] 5 [/SUP], Edwaldo Edner Joviliano[SUP] 6 [/SUP], Cesar Dusilek[SUP] 7 [/SUP], Kenji Itinose[SUP] 7 [/SUP], Rogério Aparecido Dedivitis[SUP] 8 [/SUP], André Sementilli Cortina[SUP] 8 [/SUP], Suzanna Maria Viana Sanches[SUP] 9 [/SUP], Nara Franzin de Moraes[SUP] 10 [/SUP], Paulo Fernando Guimarães Morando Marzocchi Tierno[SUP] 10 [/SUP], André Luiz Malavasi Longo de Oliveira[SUP] 11 [/SUP], Adriano Tachibana[SUP] 12 [/SUP], Rodrigo Caruso Chate[SUP] 12 [/SUP], Marcus Vinícius Barbosa Santos[SUP] 13 [/SUP], Bruno Bezerra de Menezes Cavalcante[SUP] 14 [/SUP], Ricardo Cesar Rocha Moreira[SUP] 15 [/SUP], Chang Chiann[SUP] 16 [/SUP], Alfonso Tafur[SUP] 17 [/SUP], Alex C Spyropoulos[SUP] 18 [/SUP], Renato D Lopes[SUP] 19 [/SUP]
Affiliations
- PMID: 34480880
- DOI: 10.1016/j.ahj.2021.08.016
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 post-hospital discharge and symptomatic arterial thromboembolism (myocardial infarction [MI], non-hemorrhagic stroke, major adverse limb events [MALE] and cardiovascular [CV] death) up to day 35±4 post-hospital 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.
Keywords: COVID-19; SARS-CoV-2; anticoagulation; direct oral anticoagulants; rivaroxaban; thrombosis; venous thromboembolism.