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
Condition: Cardiovascular Diseases; Statin Adverse Reaction
MeSH terms: Cardiovascular Diseases
Intervention: Bempedoic acid 180 mg tablet; Matching placebo tablet
Intervention description: Patients take bempedoic acid 180 mg tablet orally once daily; Patients take matching placebo tablet orally once daily
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 13970.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if treatment with bempedoic acid (ETC-1002) versus
      placebo decreases the risk of cardiovascular events in participants who have or are at high
      risk for cardiovascular disease and are statin intolerant.
    

Eligibility criteria:

        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

          -  Participant-reported SI due to an adverse safety effect that started or increased
             during statin therapy and resolved or improved when statin therapy was discontinued
             resulting in an inability to tolerate:

               -  2 or more statins at any dose, or

               -  1 statin at any dose and unwilling to attempt a second statin or advised by a
                  physician to not attempt a second statin.

        Please note that participants currently tolerating very low dose statin therapy (an average
        daily dose of rosuvastatin <5 mg, atorvastatin <10 mg, simvastatin <10 mg, lovastatin <20
        mg, pravastatin <40 mg, fluvastatin <40 mg, or pitavastatin <2 mg) are considered to be
        intolerant to that low dose statin. Patients may continue taking very low dose statin
        therapy throughout the study provided that it is stable (used for at least 4 weeks prior to
        screening) and well tolerated.

          -  Written confirmation by both participant and investigator that the participant is
             statin intolerant as defined above, aware of the benefit of statin use to reduce the
             risk of MACE including death, and also aware that many other participants who are
             unable to tolerate a statin are able to tolerate a different statin or 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