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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02993406




Registration number
NCT02993406
Ethics application status
Date submitted
9/12/2016
Date registered
15/12/2016
Date last updated
3/01/2024

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
1002-043
Universal Trial Number (UTN)
Trial acronym
CLEAR Outcomes
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Diseases 0 0
Statin Adverse Reaction 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bempedoic acid 180 mg tablet
Treatment: Drugs - Matching placebo tablet

Experimental: Bempedoic Acid 180 mg - Bempedoic acid 180 mg tablet taken orally, once daily.

Placebo Comparator: Placebo Comparator - Matching placebo tablet taken orally, once daily


Treatment: Drugs: Bempedoic acid 180 mg tablet
Patients take bempedoic acid 180 mg tablet orally once daily

Treatment: Drugs: Matching placebo tablet
Patients take matching placebo tablet orally once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With First Occurrence of Four Component Major Adverse Cardiovascular Events (MACE)
Timepoint [1] 0 0
Up to 68 months
Secondary outcome [1] 0 0
Number of Participants With First Occurrence of Three Component MACE
Timepoint [1] 0 0
Up to 68 months
Secondary outcome [2] 0 0
Number of Participants With First Occurrence of Myocardial Infarction
Timepoint [2] 0 0
Up to 68 months
Secondary outcome [3] 0 0
Number of Participants With Time to First Occurrence of Coronary Revascularization
Timepoint [3] 0 0
Up to 68 months
Secondary outcome [4] 0 0
Number of Participants With Time to First Occurrence of Stroke
Timepoint [4] 0 0
Up to 68 months
Secondary outcome [5] 0 0
Number of Participants With Time to Cardiovascular Death
Timepoint [5] 0 0
Up to 68 months
Secondary outcome [6] 0 0
Number of Participants With Time to All-cause Mortality
Timepoint [6] 0 0
Up to 68 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/12/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/11/2022
Sample size
Target
Accrual to date
Final
13970
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
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- Adamstown
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- Camperdown
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- Gosford
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- Liverpool
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- Merewether
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- Tumbi Umbi
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- Wollongong
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- Auchenflower
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- Bundaberg
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- Chermside
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- Milton
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- Sherwood
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- Sippy Downs
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- Woolloongabba
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- Adelaide
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- Ballarat
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- Box Hill
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- Clayton
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- Fitzroy
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- Frankston
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- Langwarrin
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- Melbourne
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- Mildura
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- Joondalup
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- Murdoch
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- Nedlands
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- Perth
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- Subiaco
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2289 - Adamstown
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2050 - Camperdown
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2250 - Gosford
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2170 - Liverpool
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2291 - Merewether
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2261 - Tumbi Umbi
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2522 - Wollongong
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4066 - Auchenflower
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4670 - Bundaberg
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4032 - Chermside
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4064 - Milton
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4075 - Sherwood
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4556 - Sippy Downs
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4102 - Woolloongabba
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5000 - Adelaide
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5035 - Ashford
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5063 - Fullarton
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7000 - Hobart
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3350 - Ballarat
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3128 - Box Hill
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3168 - Clayton
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3065 - Fitzroy
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3199 - Frankston
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3910 - Langwarrin
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3004 - Melbourne
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3500 - Mildura
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6027 - Joondalup
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6150 - Murdoch
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6009 - Nedlands
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6000 - Perth
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6008 - Subiaco
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Pleven
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Germany
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Germany
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Germany
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Germany
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Hungary
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Hungary
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India
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India
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India
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India
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India
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India
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India
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India
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India
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India
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India
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Mexico
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Mexico
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Mexico
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Mexico
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Mexico
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Mexico
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Poland
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Chelm
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Poland
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Poland
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Poland
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Poland
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Poland
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Zalau
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Russian Federation
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Altayskiy Kray
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Russian Federation
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Arkhangel'sk
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Russian Federation
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Arkhangelsk
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Russian Federation
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Barnaul
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Russian Federation
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Chelyabinsk
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Russian Federation
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Ekaterinburg
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Russian Federation
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Russian Federation
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Kazan
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Russian Federation
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Russian Federation
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Russian Federation
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Kirov
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Russian Federation
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Krasnoyarsk
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Russian Federation
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Kursk
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Russian Federation
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Moscow
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Perm
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Russian Federation
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Rostov-on-Don
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Russian Federation
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Russian Federation
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Saint Petersburg
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Smolensk
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Russian Federation
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St. Petersburg
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Russian Federation
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Tomsk
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Russian Federation
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Serbia
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Whitby

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Esperion Therapeutics, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Cleveland Clinic
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02993406
Trial related presentations / publications
Pinkosky SL, Newton RS, Day EA, Ford RJ, Lhotak S, Austin RC, Birch CM, Smith BK, Filippov S, Groot PHE, Steinberg GR, Lalwani ND. Liver-specific ATP-citrate lyase inhibition by bempedoic acid decreases LDL-C and attenuates atherosclerosis. Nat Commun. 2016 Nov 28;7:13457. doi: 10.1038/ncomms13457.
Bilen O, Ballantyne CM. Bempedoic Acid (ETC-1002): an Investigational Inhibitor of ATP Citrate Lyase. Curr Atheroscler Rep. 2016 Oct;18(10):61. doi: 10.1007/s11883-016-0611-4.
Thompson PD, MacDougall DE, Newton RS, Margulies JR, Hanselman JC, Orloff DG, McKenney JM, Ballantyne CM. Treatment with ETC-1002 alone and in combination with ezetimibe lowers LDL cholesterol in hypercholesterolemic patients with or without statin intolerance. J Clin Lipidol. 2016 May-Jun;10(3):556-67. doi: 10.1016/j.jacl.2015.12.025. Epub 2016 Jan 6.
Thompson PD, Rubino J, Janik MJ, MacDougall DE, McBride SJ, Margulies JR, Newton RS. Use of ETC-1002 to treat hypercholesterolemia in patients with statin intolerance. J Clin Lipidol. 2015 May-Jun;9(3):295-304. doi: 10.1016/j.jacl.2015.03.003. Epub 2015 Mar 19.
Nicholls S, Lincoff AM, Bays HE, Cho L, Grobbee DE, Kastelein JJ, Libby P, Moriarty PM, Plutzky J, Ray KK, Thompson PD, Sasiela W, Mason D, McCluskey J, Davey D, Wolski K, Nissen SE. Rationale and design of the CLEAR-outcomes trial: Evaluating the effect of bempedoic acid on cardiovascular events in patients with statin intolerance. Am Heart J. 2021 May;235:104-112. doi: 10.1016/j.ahj.2020.10.060. Epub 2020 Oct 24.
Nissen SE, Lincoff AM, Brennan D, Ray KK, Mason D, Kastelein JJP, Thompson PD, Libby P, Cho L, Plutzky J, Bays HE, Moriarty PM, Menon V, Grobbee DE, Louie MJ, Chen CF, Li N, Bloedon L, Robinson P, Horner M, Sasiela WJ, McCluskey J, Davey D, Fajardo-Campos P, Petrovic P, Fedacko J, Zmuda W, Lukyanov Y, Nicholls SJ; CLEAR Outcomes Investigators. Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients. N Engl J Med. 2023 Apr 13;388(15):1353-1364. doi: 10.1056/NEJMoa2215024. Epub 2023 Mar 4.
Nissen SE, Menon V, Nicholls SJ, Brennan D, Laffin L, Ridker P, Ray KK, Mason D, Kastelein JJP, Cho L, Libby P, Li N, Foody J, Louie MJ, Lincoff AM. Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients. JAMA. 2023 Jul 11;330(2):131-140. doi: 10.1001/jama.2023.9696.
Public notes

Contacts
Principal investigator
Name 0 0
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Country 0 0
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Email 0 0
Contact person for public queries
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Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02993406