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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)

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ClinicalTrials.gov Identifier: NCT02993406
Recruitment Status : Completed
First Posted : December 15, 2016
Last Update Posted : December 7, 2022
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 patients who 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 : 14014 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. Time from randomization to first occurrence of one of the following adjudicated composite endpoints: CV death, nonfatal myocardial infarction (MI), nonfatal stroke, or coronary revascularization. [ Time Frame: 3.75 years (estimated average treatment duration) ]

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
  • 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
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
Investigators
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Study Director: Michael Louie, MD Esperion Therapeutics, Inc.
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
Last Update Posted: December 7, 2022
Last Verified: December 2022
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