Impact of the COVID‐19 Pandemic on Conduct and Results of CLEAR Outcomes Trial

Author:

Singh Abhayjit1,Laffin Luke J.12ORCID,Sarraju Ashish12,Michael Lincoff A.2,Nicholls Stephen J.3ORCID,Bloedon LeAnne4,Sasiela William J.4,Li Na4,Robinson Paula4,Kelly Stephanie4,Mason Denise2,Nissen Steven E.12

Affiliation:

1. Section of Preventive Cardiology and Rehabilitation, Department of Cardiovascular Medicine Cleveland Clinic Foundation Cleveland Ohio USA

2. Cleveland Clinic Coordinating Center for Clinical Research (C5Research) Cleveland Ohio USA

3. Victorian Heart Institute Monash University Melbourne Victoria Australia

4. Esperion Therapeutics Inc. Ann Arbor Michigan USA

Abstract

ABSTRACTIntroductionThe COVID‐19 pandemic disrupted clinical research. CLEAR Outcomes investigated the effect of bempedoic acid (BA) versus placebo in 13 970 patients with statin intolerance and high cardiovascular (CV) risk. BA reduced the risk of the primary endpoint (composite of CV death, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization) by 13%. CLEAR Outcomes began before and continued for 2.7 years after the start of the pandemic.MethodsThe impact of the COVID‐19 pandemic on patient disposition, adverse events, and major adverse CV events (MACE) in CLEAR Outcomes was assessed.ResultsRates of severe infection, hospitalization, or first MACE associated with a positive COVID‐19 test were low and balanced between treatment groups. 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 etiology remained stable. A sensitivity analysis excluding undetermined deaths occurring after the onset of the pandemic from the CV death designation yielded hazard ratios of 0.84 (95% CI, 0.76–0.93) for the primary endpoint and 0.94 (95% CI, 0.76–1.16) for the secondary endpoint of CV death, compared with 0.87 (95% CI, 0.79–0.96) and 1.04 (95% CI, 0.88–1.24), respectively, in the original analysis.ConclusionThe CLEAR Outcomes trial continued uninterrupted throughout the COVID‐19 pandemic. Certain trial endpoints may have been impacted by the pandemic. Specifically, the classification of undetermined deaths as CV deaths may have attenuated the effect of BA on key efficacy endpoints.

Publisher

Wiley

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