Impact of the COVID-19 Pandemic on CLEAR Outcomes Trial
Key Findings:
The CLEAR Outcomes Trial investigated the impact of bempedoic acid (BA) versus placebo in 13,970 patients with statin intolerance and high cardiovascular risk. BA reduced the risk of the primary endpoint (composite of CV death, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization) by 13%. The trial continued for 2.7 years after the start of the pandemic.
Results:
Rates of severe infection, hospitalization, or first major adverse CV events (MACE) associated with a positive COVID-19 test were low and balanced between treatment groups. However, rates of all-cause death, non-CV death, and undetermined death increased in the pandemic period compared with the pre-pandemic period, while rates of CV death with a known cause remained stable.
Conclusion:
The CLEAR Outcomes trial continued throughout the COVID-19 pandemic. The pandemic may have impacted certain trial endpoints, particularly the classification of undetermined deaths as CV deaths, which may have affected the observed efficacy of BA.
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