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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 (CLEAR Outcomes)

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ClinicalTrials.gov Identifier: NCT02993406
Recruitment Status : Completed
First Posted : December 15, 2016
Results First Posted : January 3, 2024
Last Update Posted : January 3, 2024
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Esperion Therapeutics, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Statin Adverse Reaction Drug: Bempedoic acid 180 mg tablet Drug: Matching placebo tablet Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13970 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 22, 2016
Actual Primary Completion Date : November 7, 2022
Actual Study Completion Date : November 7, 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Bempedoic Acid 180 mg
Bempedoic acid 180 mg tablet taken orally, once daily.
 Drug: Bempedoic acid 180 mg tablet
Patients take bempedoic acid 180 mg tablet orally once daily
Other Name: ETC-1002
Placebo Comparator: Placebo Comparator
Matching placebo tablet taken orally, once daily
 Drug: Matching placebo tablet
Patients take matching placebo tablet orally once daily
Other Name: placebo comparator


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With First Occurrence of Four Component Major Adverse Cardiovascular Events (MACE) [ Time Frame: Up to 68 months ]
    The primary efficacy end point was a four-component composite of adjudicated MACE, defined as death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization, as assessed in a time-to first-event analysis.


Secondary Outcome Measures :
  1. Number of Participants With First Occurrence of Three Component MACE [ Time Frame: Up to 68 months ]
    The first key secondary end point was a three-component MACE, defined as death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke.

  2. Number of Participants With First Occurrence of Myocardial Infarction [ Time Frame: Up to 68 months ]
    Number of participants with time to first occurrence of fatal and non-fatal myocardial infarction are presented.

  3. Number of Participants With Time to First Occurrence of Coronary Revascularization [ Time Frame: Up to 68 months ]
    Number of participants with time to first occurrence of coronary revascularization are presented.

  4. Number of Participants With Time to First Occurrence of Stroke [ Time Frame: Up to 68 months ]
    Number of participants with time to first occurrence of fatal and non-fatal stroke.

  5. Number of Participants With Time to Cardiovascular Death [ Time Frame: Up to 68 months ]
    Number of participants with time to cardiovascular death are presented.

  6. Number of Participants With Time to All-cause Mortality [ Time Frame: Up to 68 months ]
    All-cause mortality is death due to any cause. Number of participants with time to all-cause mortality are presented.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02993406


Locations
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Sponsors and Collaborators
Esperion Therapeutics, Inc.
The Cleveland Clinic
  Study Documents (Full-Text)

Documents provided by Esperion Therapeutics, Inc.:
Study Protocol  [PDF] September 24, 2020
Statistical Analysis Plan  [PDF] November 14, 2022

More Information
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Publications:

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Responsible Party: Esperion Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02993406    
Other Study ID Numbers: 1002-043
First Posted: December 15, 2016    Key Record Dates
Results First Posted: January 3, 2024
Last Update Posted: January 3, 2024
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Cardiovascular Diseases
8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Lipid Regulating Agents
Enzyme Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs