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Active Clinical Trials

A Randomized, Double-Blind, Placebo-Controlled Study to Assess The Effects of Bempedoic Acid (ETC-1002) on the Occurrence of Major Cardiovascular Events in Patients with, or at High Risk for, Cardiovascular Disease who are Statin Intolerant

Active NCT:
02993406
Allegheny Valley Hospital
Allegheny Valley Hospital

Tri CountyCardiology in Lower Burrel
Tri CountyCardiology in Lower Burrel

Tri CountyCardiology in Natrona Heights
Tri CountyCardiology in Natrona Heights

West Penn Hospital
West Penn Hospital

Sponsor: 
Esperion Therapeutics
Contact: 

For more information, please contact Jessica Burkardt at 724-226-7460 or Jessica.Burkardt@ahn.org.

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)

Purpose: 

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.

Inclusion Criteria:

  • 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
  • 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

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
Eligibility Criteria: 
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No