Cardiovascular Atlas
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CLEAR Outcomes (bempedoic acid in statin-intolerant people)

A large trial of 13,970 people who could not or would not take statins because of side effects and who had, or were at high risk of, cardiovascular disease. Half took bempedoic acid, a daily pill, and half took placebo. Bempedoic acid lowered LDL cholesterol and the rate of a combined set of heart events, but the trial did not show an effect on death.

Also called CLEAR Outcomes

  • Study
  • In this atlas

Overview

Design
Allocation: randomized. Intervention model: parallel. Masking: triple. Primary purpose: treatment. (Registry values, in lower case.)
Phase
Phase 3
Enrolled
  • 13,970 participants (enrolled count) (Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo, retrieved )
Sponsor
Not recorded
Funder
Not recorded
Registry
  • NCT NCT02993406
Started
(actual) (Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo, retrieved )
Primary completion
(actual) (Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo, retrieved )
Completion
(actual) (Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo, retrieved )
Results first posted
(actual) (Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo, retrieved )
Countries
United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czechia, Denmark, Estonia, Germany, Hungary, India, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Russia, Serbia, Slovakia, South Africa, Spain, Ukraine, United Kingdom, Türkiye (Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo, retrieved )
Care setting
Not reported
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

Phase 3, randomized, double-blind, placebo-controlled trial (NCT02993406), 13,970 participants enrolled, started 2016-12-22 and primary completion 2022-11-07. The abstract reports the primary composite in 11.7% against 13.3% (hazard ratio 0.87, 95% CI 0.79 to 0.96), and no significant effects on fatal or nonfatal stroke, death from cardiovascular causes, or death from any cause. Funded by Esperion Therapeutics according to the paper; Esperion is the registry lead sponsor and the Cleveland Clinic a collaborator.

Arms

  • Bempedoic Acid 180 mg

    Intervention None named

    Bempedoic acid 180 mg tablet taken orally, once daily.

  • Placebo Comparator

    Intervention None named

    Matching placebo tablet taken orally, once daily

Findings

No findings are published for this study.

Record details

Record id
cardio:clear-outcomes
Content hash
cea35cae973208e60eb619f85ab4578010b61569c0fd2a132f62bafc39c9f915