Skip to main content
Journal cover image

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

Publication ,  Journal Article
Ramacciotti, E; Agati, LB; Calderaro, D; Volpiani, GG; de Oliveira, CCC; Aguiar, VCR; Rodrigues, E; Sobreira, ML; Joviliano, EE; Dusilek, C ...
Published in: Am Heart J
December 2021

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.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

December 2021

Volume

242

Start / End Page

115 / 122

Location

United States

Related Subject Headings

  • Venous Thrombosis
  • Thrombosis
  • Thromboembolism
  • Rivaroxaban
  • Randomized Controlled Trials as Topic
  • Pulmonary Embolism
  • Prospective Studies
  • Multicenter Studies as Topic
  • Male
  • Humans
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Ramacciotti, E., Agati, L. B., Calderaro, D., Volpiani, G. G., de Oliveira, C. C. C., Aguiar, V. C. R., … Lopes, R. D. (2021). Medically Ill hospitalized Patients for COVID-19 THrombosis Extended ProphyLaxis with rivaroxaban ThErapy: Rationale and Design of the MICHELLE Trial. Am Heart J, 242, 115–122. https://doi.org/10.1016/j.ahj.2021.08.016
Ramacciotti, Eduardo, Leandro Barile Agati, Daniela Calderaro, Giuliano Giova Volpiani, Caroline Candida Carvalho de Oliveira, Valéria Cristina Resende Aguiar, Elizabeth Rodrigues, et al. “Medically Ill hospitalized Patients for COVID-19 THrombosis Extended ProphyLaxis with rivaroxaban ThErapy: Rationale and Design of the MICHELLE Trial.Am Heart J 242 (December 2021): 115–22. https://doi.org/10.1016/j.ahj.2021.08.016.
Ramacciotti E, Agati LB, Calderaro D, Volpiani GG, de Oliveira CCC, Aguiar VCR, et al. Medically Ill hospitalized Patients for COVID-19 THrombosis Extended ProphyLaxis with rivaroxaban ThErapy: Rationale and Design of the MICHELLE Trial. Am Heart J. 2021 Dec;242:115–22.
Ramacciotti, Eduardo, et al. “Medically Ill hospitalized Patients for COVID-19 THrombosis Extended ProphyLaxis with rivaroxaban ThErapy: Rationale and Design of the MICHELLE Trial.Am Heart J, vol. 242, Dec. 2021, pp. 115–22. Pubmed, doi:10.1016/j.ahj.2021.08.016.
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. Medically Ill hospitalized Patients for COVID-19 THrombosis Extended ProphyLaxis with rivaroxaban ThErapy: Rationale and Design of the MICHELLE Trial. Am Heart J. 2021 Dec;242:115–122.
Journal cover image

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

December 2021

Volume

242

Start / End Page

115 / 122

Location

United States

Related Subject Headings

  • Venous Thrombosis
  • Thrombosis
  • Thromboembolism
  • Rivaroxaban
  • Randomized Controlled Trials as Topic
  • Pulmonary Embolism
  • Prospective Studies
  • Multicenter Studies as Topic
  • Male
  • Humans