Intermediate Versus Standard-Dose Prophylactic Anticoagulation in Critically Ill Patients With COVID-19 - INSPIRATION-S

Contribution To Literature:

The INSPIRATION-S trial failed to show that atorvastatin was beneficial in critically ill COVID-19 patients.


The goal of the trial was to evaluate atorvastatin compared with placebo among patients admitted to the intensive care unit (ICU) with coronavirus disease 2019 (COVID-19) infection.

Study Design

  • Randomized
  • Parallel
  • Stratification
  • Double-blind

Patients admitted to the ICU with COVID-19 infection were randomized to atorvastatin 20 mg daily (n = 303) versus placebo (n = 302).

  • Total number of enrollees: 605
  • Duration of follow-up: 30 days
  • Mean patient age: 57 years
  • Percentage female: 43%
  • Percentage with diabetes: 17%

Inclusion criteria:

  • Critically ill patients with COVID-19 infection

Exclusion criteria:

  • Liver function tests >6 times the upper limit of normal (>3 times the upper limit of normal plus findings of cirrhosis)
  • Creatine kinase >500 U/L
  • Routine statin use prior to hospitalization
  • Statin intolerance

Principal Findings:

The primary outcome of all-cause death, venous or arterial thrombosis, or treatment with extracorporeal membrane oxygenation, occurred in 32.7% of the atorvastatin group compared with 36.3% of the placebo group (p = 0.35).

Secondary outcomes:

  • Major bleeding (Bleeding Academic Research Consortium [BARC] 3 or 5): in 3.7% of the atorvastatin group compared with 1.6% of the placebo group (p = 0.12)


Among critically ill patients with COVID-19 infection, atorvastatin was not beneficial. Atorvastatin compared with placebo was not associated with a reduction in composite adverse events. Atorvastatin did not increase bleeding events.


Presented by Dr. Behnood Bikdeli at the American College of Cardiology Virtual Annual Scientific Session (ACC 2021), May 16, 2021.

Clinical Topics: Anticoagulation Management, COVID-19 Hub, Dyslipidemia, Prevention, Vascular Medicine, Nonstatins, Novel Agents, Statins

Keywords: ACC21, ACC Annual Scientific Session, Anticoagulants, Coronavirus, Coronavirus Infections, COVID-19, Critical Illness, Extracorporeal Membrane Oxygenation, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Intensive Care Units, Liver Function Tests, Primary Prevention, Thrombosis, Venous Thrombosis

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