Clinical trial NCT02993406: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiovascular Diseases
Statin Adverse Reaction
Lead sponsor: Esperion Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: The Cleveland Clinic
First posted: 2016-12-15
Enrollment: 13970
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants With First Occurrence of Four Component Major Adverse Cardiovascular Events (MACE)
timeFrame: Up to 68 months
Secondary outcomes:
measure: Number of Participants With First Occurrence of Three Component MACE
timeFrame: Up to 68 months
measure: Number of Participants With First Occurrence of Myocardial Infarction
timeFrame: Up to 68 months
measure: Number of Participants With Time to First Occurrence of Coronary Revascularization
timeFrame: Up to 68 months
measure: Number of Participants With Time to First Occurrence of Stroke
timeFrame: Up to 68 months
measure: Number of Participants With Time to Cardiovascular Death
timeFrame: Up to 68 months
measure: Number of Participants With Time to All-cause Mortality
timeFrame: Up to 68 months
Other outcomes:
Locations:
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country: Poland
city: Oświęcim
country: Poland
city: Poznań
country: Poland
city: Poznań
country: Poland
city: Poznań
country: Poland
city: Pulawy
country: Poland
city: Puławy
country: Poland
city: Płock
country: Poland
city: Ruda Śląska
country: Poland
city: Ruda Śląska
country: Poland
city: Rzeszów
country: Poland
city: Rzeszów
country: Poland
city: Rzeszów
country: Poland
city: Siedlce
country: Poland
city: Skierniewice
country: Poland
city: Sopot
country: Poland
city: Staszów
country: Poland
city: Szczecin
country: Poland
city: Szczecin
country: Poland
city: Tarnów
country: Poland
city: Tczew
country: Poland
city: Toruń
country: Poland
city: Warsaw
country: Poland
city: Warsaw
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Wroclaw
country: Poland
city: Wrocław
country: Poland
city: Wrocław
country: Poland
city: Włocławek
country: Poland
city: Zamość
country: Poland
city: Łódź
country: Poland
city: Łódź
country: Poland
city: Łódź
country: Poland
city: Łódź
country: Poland
city: Łódź
country: Poland
city: Łódź
country: Poland
city: Łódź
country: Poland
city: Łódź
country: Poland
city: Pitesti
country: Romania
state: Arges
city: Baia Mare
country: Romania
state: Maramures County
city: Satu Mare
country: Romania
state: Satu Mare County
city: Timişoara
country: Romania
state: Timis County
city: Alba Iulia
country: Romania
city: Baia Mare
country: Romania
city: Baia Mare
country: Romania
city: Baloteşti
country: Romania
city: Braila
country: Romania
city: Braşov
country: Romania
city: Braşov
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Calarasi
country: Romania
city: Cluj-Napoca
country: Romania
city: Craiova
country: Romania
city: Deva
country: Romania
city: Galaţi
country: Romania
city: Galaţi
country: Romania
city: Oradea
country: Romania
city: Oradea
country: Romania
city: Oradea
country: Romania
city: Oradea
country: Romania
city: Paşcani
country: Romania
city: Pitesti
country: Romania
city: Ploieşti
country: Romania
city: Satu Mare
country: Romania
city: Timisoara
country: Romania
city: Timişoara
country: Romania
city: Timişoara
country: Romania
city: Târgu-Mureş
country: Romania
city: Târgu-Mureş
country: Romania
city: Târgu-Mureş
country: Romania
city: Târgu-Mureş
country: Romania
city: Zalău
country: Romania
city: Barnaul
country: Russian Federation
state: Altayskiy Kray
city: Arkhangel'sk
country: Russian Federation
city: Arkhangelsk
country: Russian Federation
city: Barnaul
country: Russian Federation
city: Chelyabinsk
country: Russian Federation
city: Chelyabinsk
country: Russian Federation
city: Ekaterinburg
country: Russian Federation
city: Ekaterinburg
country: Russian Federation
city: Ekaterinburg
country: Russian Federation
city: Ivanovo
country: Russian Federation
city: Kazan
country: Russian Federation
city: Kemerovo
country: Russian Federation
city: Kemerovo
country: Russian Federation
city: Kemerovo
country: Russian Federation
city: Kirovsk
country: Russian Federation
city: Kirov
country: Russian Federation
city: Kirov
country: Russian Federation
city: Krasnoyarsk
country: Russian Federation
city: Kursk
country: Russian Federation
city: Kursk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhniy Novgorod
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Omsk
country: Russian Federation
city: Omsk
country: Russian Federation
city: Orenburg
country: Russian Federation
city: Perm
country: Russian Federation
city: Rostov-on-Don
country: Russian Federation
city: Ryazan'
country: Russian Federation
city: Ryazan'
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Saratov
country: Russian Federation
city: Sestroretsk
country: Russian Federation
city: Smolensk
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Belgrade
country: Serbia
city: Belgrade
country: Serbia
city: Belgrade
country: Serbia
city: Kragujevac
country: Serbia
city: Niš
country: Serbia
city: Pančevo
country: Serbia
city: Smederevo
country: Serbia
city: Sremska Mitrovica
country: Serbia
city: Užice
country: Serbia
city: Valjevo
country: Serbia
city: Zaječar
country: Serbia
city: Bratislava 2
country: Slovakia
state: Ružinov
city: Bardejov
country: Slovakia
city: Bratislava
country: Slovakia
city: Bratislava
country: Slovakia
city: Bratislava
country: Slovakia
city: Bratislava
country: Slovakia
city: Dolný Kubín
country: Slovakia
city: Komarno
country: Slovakia
city: Košice
country: Slovakia
city: Košice
country: Slovakia
city: Košice
country: Slovakia
city: Košice
country: Slovakia
city: Levice
country: Slovakia
city: Levice
country: Slovakia
city: Lucenec
country: Slovakia
city: Lučenec
country: Slovakia
city: Lučenec
country: Slovakia
city: Moldava Nad Bodvou
country: Slovakia
city: Nitra
country: Slovakia
city: Nove Zamky
country: Slovakia
city: Nové Zámky
country: Slovakia
city: Prešov
country: Slovakia
city: Rožňava
country: Slovakia
city: Sahy
country: Slovakia
city: Svidnik
country: Slovakia
city: Svidník
country: Slovakia
city: Ľubochňa
country: Slovakia
city: Štúrovo
country: Slovakia
city: Žilina
country: Slovakia
city: Port Elizabeth
country: South Africa
state: Eastern Cape
city: Port Elizabeth
country: South Africa
state: Eastern Cape
city: Bloemfontein
country: South Africa
state: Free State
city: Bloemfontein
country: South Africa
state: Free State
city: Centurion
country: South Africa
state: Gauteng
city: Johannesburg
country: South Africa
state: Gauteng
city: Johannesburg
country: South Africa
state: Gauteng
city: Johannesburg
country: South Africa
state: Gauteng
city: Kempton Park
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Alberton
country: South Africa
state: Guateng
city: Pretoria
country: South Africa
state: Guateng
city: Pretoria
country: South Africa
state: Guateng
city: Durban
country: South Africa
state: KwaZulu-Natal
city: Durban
country: South Africa
state: KwaZulu-Natal
city: Durban
country: South Africa
state: KwaZulu-Natal
city: Merebank
country: South Africa
state: KwaZulu-Natal
city: Thabazimbi
country: South Africa
state: Limpopo
city: Middelburg
country: South Africa
state: Mpumalanga
city: Moloto
country: South Africa
state: Mpumalanga
city: Cape Town
country: South Africa
state: Western Cape
city: Cape Town
country: South Africa
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city: Cape Town
country: South Africa
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city: Cape Town
country: South Africa
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city: Cape Town
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city: Cape Town
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city: Cape Town
country: South Africa
state: Western Cape
city: Somerset West
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city: Worcester
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city: Santiago De Compostela
country: Spain
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city: A Coruña
country: Spain
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country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Girona
country: Spain
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city: Madrid
country: Spain
city: Málaga
country: Spain
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country: Spain
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country: Spain
city: Sevilla
country: Spain
city: Adana
country: Turkey
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country: Turkey
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country: Turkey
city: Edirne
country: Turkey
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country: Turkey
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country: Turkey
city: Istanbul
country: Turkey
city: Istanbul
country: Turkey
city: Izmir
country: Turkey
city: Kocaeli
country: Turkey
city: Mersin
country: Turkey
city: Sivas
country: Turkey
city: Brovary
country: Ukraine
city: Cherkasy
country: Ukraine
city: Chernivtsi
country: Ukraine
city: Dnipro
country: Ukraine
city: Dnipro
country: Ukraine
city: Dnipro
country: Ukraine
city: Dnipro
country: Ukraine
city: Ivano-Frankivs'k
country: Ukraine
city: Ivano-Frankivs'k
country: Ukraine
city: Ivano-Frankivsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kharkiv
country: Ukraine
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country: Ukraine
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country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
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country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
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country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Luts'k
country: Ukraine
city: Lviv
country: Ukraine
city: Lviv
country: Ukraine
city: Mykolaiv
country: Ukraine
city: Odesa
country: Ukraine
city: Sumy
country: Ukraine
city: Ternopil
country: Ukraine
city: Vinnytsia
country: Ukraine
city: Vinnytsia
country: Ukraine
city: Vinnytsia
country: Ukraine
city: Vinnytsia
country: Ukraine
city: Vinnytsia
country: Ukraine
city: Vinnytsya
country: Ukraine
city: Zaporizhzhia
country: Ukraine
city: Zaporizhzhia
country: Ukraine
city: Zaporizhzhia
country: Ukraine
city: Zaporizhzhia
country: Ukraine
city: Zaporizhzhia
country: Ukraine
city: Zaporizhzhia
country: Ukraine
city: Zhytomyr
country: Ukraine
city: Úzhgorod
country: Ukraine
city: Reading
country: United Kingdom
state: Berkshire
city: Soham
country: United Kingdom
state: Cambridgeshire
city: Fowey
country: United Kingdom
state: Cornwall
city: Hayle
country: United Kingdom
state: Cornwall
city: Torpoint
country: United Kingdom
state: Cornwall
city: Exmouth
country: United Kingdom
state: Devon
city: Plymouth
country: United Kingdom
state: Devon
city: Plymouth
country: United Kingdom
state: Devon
city: Stockton on Tees
country: United Kingdom
state: Durham
city: Basildon
country: United Kingdom
state: Essex
city: London
country: United Kingdom
state: Greater London
city: Manchester
country: United Kingdom
state: Greater Manchester
city: East Kilbride
country: United Kingdom
state: Lanarkshire
city: Blackpool
country: United Kingdom
state: Lancashire
city: Chorley
country: United Kingdom
state: Lancashire
city: Edinburgh
country: United Kingdom
state: Lothian Region
city: Liverpool
country: United Kingdom
state: Merseyside
city: Airdrie
country: United Kingdom
state: North Lanarkshire
city: Hexham
country: United Kingdom
state: Northumberland
city: Axbridge
country: United Kingdom
state: Somerset
city: Bath
country: United Kingdom
state: Somerset
city: Cardiff
country: United Kingdom
state: South Glamorgan
city: Glasgow
country: United Kingdom
state: Strathclyde
city: Chertsey
country: United Kingdom
state: Surrey
city: Dundee
country: United Kingdom
state: Tayside Region
city: Birmingham
country: United Kingdom
state: West Midlands
city: Wakefield
country: United Kingdom
state: Yorkshire And The Humber
city: Wakefield
country: United Kingdom
state: Yorkshire
city: Blackpool
country: United Kingdom
city: Chesterfield
country: United Kingdom
city: Crownhill
country: United Kingdom
city: Leamington Spa
country: United Kingdom
city: Lincoln
country: United Kingdom
city: Oldham
country: United Kingdom
city: Sandbach
country: United Kingdom
city: Whitby
country: United Kingdom
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.