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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age between 18 and 85 years.
  • 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 ≥ 100 (2.6 mmol/L) at screening.

Exclusion Criteria:

  • Fasting blood triglycerides greater than 500 mg/dL (5.6 mmol/L) at screening.
  • Recent (within 90 days of screening) history of major cardiovascular events, transient ischemic attack (TIA), or unstable or symptomatic cardiac arrhythmia.
  • History of severe heart failure.
  • Uncontrolled hypertension or uncontrolled diabetes.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

La Crosse, Wis.

Mayo Clinic principal investigator

Tahir Tak, M.D., Ph.D.

Closed for enrollment

More information

Publications

Publications are currently not available
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CLS-20338652

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