MICHELLE Trial 2021 (Rivaroxaban in COVID-19)

 The trial's purpose was to compare rivaroxaban to placebo in patients discharged from the hospital with coronavirus disease 2019 (COVID-19) infection.



Design of the Study


Participants who were discharged after being infected with COVID-19 were randomly assigned to receive rivaroxaban 10 mg daily (n = 160) or a placebo (n = 160).


The total number of enrollees: 320.

Follow-up period: 35 days

The average patient age was 58 years.

39% of the population was female.


Criteria for inclusion:


  1. More than the age of 18
  2. COVID-19 infection required hospitalization for at least three days.
  3. Thromboprophylaxis at a normal dose
  4. Total modified IMPROVE VTE Risk Score 4, or Total modified IMPROVE VTE Risk Score 2 or 3 and D-dimer >500 ng/ml



Important Findings:


At 35 days, the primary outcome, a composite of symptomatic VTE, VTE-related death, bilateral VTE, symptomatic arterial thromboembolism, myocardial infarction, non-hemorrhagic stroke, major adverse limb event, or cardiovascular death, was 3.14 percent in the rivaroxaban group versus 9.43 percent in the control group (p = 0.03).


The use of rivaroxaban for 35 days following a COVID-19 infection was found to be effective in individuals who were discharged. Rivaroxaban was linked to a decrease in clinical events without increasing severe hemorrhage.


This small trial found that taking rivaroxaban after being admitted to the hospital for COVID-19 reduced the composite of symptomatic venous thromboembolism (VTE), VTE-related death, bilateral VTE, symptomatic arterial thromboembolism, MI, non-hemorrhagic stroke, major adverse limb event, or cardiovascular death at 35 days without increasing bleeding.


Other trials have revealed that medically unwell (non-COVID 19) individuals who may continue to have limited mobility at home while convalescing may benefit from anticoagulation after discharge.

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