Resumen

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 85 YearsSexo: ALL

Criterios de inclusión

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:
or more statins at any dose, or
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

Criterios de exclusión

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

Intervenciones

drug

Bempedoic acid 180 mg tablet

Patients take bempedoic acid 180 mg tablet orally once daily

drug

Matching placebo tablet

Patients take matching placebo tablet orally once daily

Ubicaciones

Bahía Blanca, Buenos Aires, Argentina

Berazategui, Buenos Aires, Argentina

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Coronel Suárez, Buenos Aires, Argentina

Haedo, Buenos Aires, Argentina

La Plata, Buenos Aires, Argentina

Mar del Plata, Buenos Aires, Argentina

Morón, Buenos Aires, Argentina

San Fernando, Buenos Aires, Argentina

San Martín, Buenos Aires, Argentina

Vicente López, Buenos Aires, Argentina

Zárate, Buenos Aires, Argentina

Villa Luro, Ciudad Autonoma Buenos Aires, Argentina

Caba, Ciudad Autonoma, Argentina

Ciudad Autónoma de Buenos Aire, Ciudad Autonoma, Argentina

Córdoba, Córdoba Province, Argentina

San Vicente, Córdoba Province, Argentina

Godoy Cruz, Mendoza Province, Argentina

San Rafael, Mendoza Province, Argentina

Temperley, Partido De Lomas De Zamora, Argentina

Rosario, Santa Fe Province, Argentina

Rosario, Sante Fe, Argentina

San Miguel de Tucumán, Tucumán Province, Argentina

Buenos Aires, Argentina

Ciudad Autonoma Buenos Aires, Argentina

Corrientes, Argentina

Córdoba, Argentina

La Plata, Argentina

Lanús, Argentina

Morón, Argentina

Pilar, Argentina

Quilmes, Argentina

Ramos Mejía, Argentina

Rosario, Argentina

Salta, Argentina

San Lorenzo, Argentina

San Miguel de Tucumán, Argentina

Santa Fe, Argentina

Patrocinadores

PrincipalEsperion Therapeutics, Inc.

ColaboradorThe Cleveland Clinic

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