CLEAR Outcomes: 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

Sponsor
Esperion Therapeutics, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02993406
Collaborator
The Cleveland Clinic (Other)
14,014
1360
2
72.4
10.3
0.1

Study Details

Study Description

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
  • Drug: Bempedoic acid 180 mg tablet
  • Drug: Matching placebo tablet
Phase 3

Study Design

Study Type:
Interventional
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 :
Nov 18, 2016
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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 Names:
  • 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 Names:
  • placebo comparator
  • Outcome Measures

    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. [3.75 years (estimated average treatment duration)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

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    1279 Ivano-Frankivs'k Ukraine 76008
    1280 Ivano-Frankivs'k Ukraine 76018
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    1282 Kharkiv Ukraine 61002
    1283 Kharkiv Ukraine 61039
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    1299 SI NSC M.D. Strazhesko Institute of Cardiology of NAMSU Kyiv Ukraine 03680
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    1302 Kyiv Ukraine 04053
    1303 Luts'k Ukraine 43024
    1304 Lviv Ukraine 79011
    1305 Lviv Ukraine 79015
    1306 Mykolaiv Ukraine 54003
    1307 Odesa Ukraine 65025
    1308 Sumy Ukraine 40021
    1309 Ternopil Ukraine 46010
    1310 Vinnytsia Ukraine 21001
    1311 Vinnytsia Ukraine 21005
    1312 Vinnytsia Ukraine 21009
    1313 Vinnytsia Ukraine 21018
    1314 Vinnytsia Ukraine 21029
    1315 Vinnytsya Ukraine 21009
    1316 Zaporizhzhia Ukraine 60106
    1317 Zaporizhzhia Ukraine 69001
    1318 Zaporizhzhia Ukraine 69005
    1319 Zaporizhzhia Ukraine 69063
    1320 Zaporizhzhia Ukraine 69104
    1321 Zaporizhzhia Ukraine 69600
    1322 Zhytomyr regional clinical hospital n.a. O.F. Gerbachevskyy Zhytomyr Ukraine 10002
    1323 Zhytomyr Ukraine 10002
    1324 Úzhgorod Ukraine 88014
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    1326 Soham Cambridgeshire United Kingdom CB7 5JD
    1327 Fowey Cornwall United Kingdom PL23 1DT
    1328 Hayle Cornwall United Kingdom TR27 5DT
    1329 Torpoint Cornwall United Kingdom PL11 2TB
    1330 Exmouth Devon United Kingdom EX8 2JF
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    Sponsors and Collaborators

    • Esperion Therapeutics, Inc.
    • The Cleveland Clinic

    Investigators

    • Study Director: Michael Louie, MD, Esperion Therapeutics, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Esperion Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT02993406
    Other Study ID Numbers:
    • 1002-043
    First Posted:
    Dec 15, 2016
    Last Update Posted:
    Sep 14, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 14, 2021