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Posted on 2 February 2021 | Posted in Evolocumab
Trial Evolocumab for PCSK9 Lowering in Early Acute Sepsis (The PLEASe Study) Identifier: NCT03869073

Aim To evaluate evolocumab in patients with early acute sepsis
Study design Randomized, double-blind, placebo-controlled study. Upon enrolling in the study patients will be randomized to treatment with evolocumab 420 mg single dose at baseline, evolocumab 840 mg single dose at baseline, or placebo
Patients Patients aged at least 19 years with known or suspected infection

AND one or more of the following organ dysfunctions judged due to sepsis:

  • Cardiovascular- refractory hypotension (a systolic blood pressure SBP < 90 mm Hg or mean arterial pressure (MAP) < 60 mm Hg despite an IV fluid challenge of at least 30 ml/kg fluids), or use of vasopressor(s) to maintain SBP >90 mm Hg or MAP > 60 mm Hg, or;
  • Respiratory: PaO2/FiO2 < 300 or PaO2/FiO2 < 200 if lung is the only organ dysfunction or SaO2:FiO2 150
Primary outcome Area under the plasma LTA and LPS curves at 7 days or less. As data are collected from patients only while they are admitted to critical care, they may be discharged or moved to a different ward before day 7 and therefore subsequent time points would be not be collected.
Key results Ongoing
Author conclusion

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