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

Journal Article (Journal Article;Multicenter Study)

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.

Full Text

Duke Authors

Cited Authors

  • Ramacciotti, E; Agati, LB; Calderaro, D; Volpiani, GG; de Oliveira, CCC; Aguiar, VCR; Rodrigues, E; Sobreira, ML; Joviliano, EE; Dusilek, C; Itinose, K; Dedivitis, RA; Cortina, AS; Sanches, SMV; de Moraes, NF; Tierno, PFGMM; de Oliveira, ALML; Tachibana, A; Chate, RC; Santos, MVB; Cavalcante, BBDM; Moreira, RCR; Chiann, C; Tafur, A; Spyropoulos, AC; Lopes, RD

Published Date

  • December 2021

Published In

Volume / Issue

  • 242 /

Start / End Page

  • 115 - 122

PubMed ID

  • 34480880

Pubmed Central ID

  • PMC8409017

Electronic International Standard Serial Number (EISSN)

  • 1097-6744

Digital Object Identifier (DOI)

  • 10.1016/j.ahj.2021.08.016

Language

  • eng

Conference Location

  • United States