2021
DOI: 10.1016/j.ahj.2020.10.060
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Rationale and design of the CLEAR-outcomes trial: Evaluating the effect of bempedoic acid on cardiovascular events in patients with statin intolerance

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Cited by 99 publications
(77 citation statements)
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“…This ongoing trial randomized more than 14,000 patients with a history of possible statin-associated side effects, and who have established CVD or are at high risk for CVD, to receive either bempedoic acid or placebo. The CLEAR Outcomes trial will evaluate the incidence of major cardiovascular events in both groups [54], and results are expected to be reported in 2023.…”
Section: Discussionmentioning
confidence: 99%
See 1 more Smart Citation
“…This ongoing trial randomized more than 14,000 patients with a history of possible statin-associated side effects, and who have established CVD or are at high risk for CVD, to receive either bempedoic acid or placebo. The CLEAR Outcomes trial will evaluate the incidence of major cardiovascular events in both groups [54], and results are expected to be reported in 2023.…”
Section: Discussionmentioning
confidence: 99%
“…The cost-effectiveness of bempedoic acid in different countries will depend on the different healthcare systems, drug pricing, and populations within each country. Results of the CLEAR Outcomes clinical endpoint study [54] will be required to establish the true cost-effectiveness of bempedoic acid. The only cost-effectiveness analysis for bempedoic acid conducted to date was based on an Australian healthcare model [55]; however, the Institute for Clinical Economic Review (ICER) has announced that a cost-effectiveness analysis for bempedoic acid in the USA is ongoing and should be available in early 2021.…”
Section: Cost-effectivenessmentioning
confidence: 99%
“…The trial will continue until 1620 patients will experience a primary endpoint and minimum treatment duration of 36 months with a projected median treatment exposure of 42 months. 9 …”
Section: Bempedoic Acidmentioning
confidence: 99%
“…While it is notable that adjudicated major adverse cardiovascular event rates were lower in the bempedoic acid treatment arms in both trials, these were trends that did not reach statistical significance. CLEAR Outcomes, a large phase 3 clinical outcomes trial with bempedoic acid, is ongoing with results anticipated in 2022-23 (discussed below) 72 .…”
Section: Introductionmentioning
confidence: 99%
“…CLEAR Outcomes (NCT02993406), the first phase 3 clinical outcomes trial studying bempedoic acid, has randomized 14,014 patients with statin intolerance, LDL-C ≥2.6 mmol/L (100 mg/dL), and high risk for ASCVD to either bempedoic acid 180 mg daily or matching placebo 72 . The primary endpoint is a composite of cardiovascular death, non-fatal MI, non-fatal stroke, or coronary revascularization and the estimated average treatment duration is 3.75 years.…”
Section: Introductionmentioning
confidence: 99%