Evaluation of Major Cardiovascular Events in Patients With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo (CLEAR Outcomes)

Trial Purpose and Description

The purpose of this study is to determine if treatment with bempedoic acid (ETC-1002) versus placebo decreases the risk of cardiovascular events in patients who are statin intolerant.

Ages: 18 years and older

Gender: Both


Eligibility Criteria

Inclusion Criteria:

  • History of, or at high risk for, cardiovascular disease (CVD) including coronary artery disease, symptomatic peripheral arterial disease, cerebrovascular atherosclerotic disease, or at high risk for a cardiovascular event
  • Patient reported history of statin intolerance (inability to tolerate 2 or more statins, one at a low dose)
  • Men and nonpregnant, nonlactating women
  • Fasting blood LDL-cholesterol between 100 and 190 mg/dL at screening

Exclusion Criteria:

  • Fasting blood triglycerides greater than 500 mg/dL at screening
  • Recent history of certain cardiovascular disease including transient ischemic attack (TIA), unstable or symptomatic cardiac arrhythmia, use of an implantable pacemaker or implantable cardioverter defibrillators, or coronary revascularization procedure
  • History of heart failure
  • Uncontrolled hypertension

Esperion Therapeutics

Dates: 10/17/2017 - 12/31/2021

Last Updated: 10/19/2017

Study HIC#: 2000020628

Get Involved

For more information about this study, contact:
Nancy J. Hinchion
203-453-7056
nancy.hinchion@yale.edu

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 1-877-978-8348.

Trial Image

Investigators

Jaime Gerber

Principal Investigator

Sub-Investigators