This study will assess the effect of lowering low-density lipoprotein cholesterol (LDL-C) with evolocumab on major cardiovascular events in adults without a prior myocardial infarction (MI) or stroke who are at high risk of a cardiovascular event.

Elegibilidad

Edad mínima: 50 YearsEdad máxima: 79 YearsSexo: ALL

Criterios de inclusión

Age: Adult participants ≥ 50 (men) or ≥ 55 (women) to ˂ 80 years of age (either sex) and meeting lipid criteria.
Lipid Criteria: Low-density lipoprotein cholesterol (LDL-C) ≥ 90 mg/dL (≥ 2.3 mmol/L) or non high-density lipoprotein cholesterol (non-HDL)-C ≥ 120 mg/dL (≥ 3.1 mmol/L), or apolipoprotein B ≥ 80 mg/dL (≥ 1.56 µmol/L).
Diagnostic evidence of at least one of the following (A-D) at screening:
A.Significant coronary artery disease (CAD) meeting at least 1 of the following criteria:
History of coronary revascularization with multi-vessel coronary disease as evidenced by any of the following:
percutaneous coronary intervention (PCI) of 2 or more vessels, including branch arteries,
PCI or coronary artery bypass grafting (CABG) with residual 50% stenosis in a separate, unrevascularized vessel, or
multi-vessel CABG 5 years or more prior to screening.
Significant coronary disease without prior revascularization as evidenced by either a ≥70% stenosis of at least 1 coronary artery, ≥50% stenosis of 2 or more coronary arteries, or ≥50% stenosis of the left main coronary artery.
known coronary artery calcium score ≥100 in participants without a coronary artery revascularization prior to randomization.
B. Significant atherosclerotic cerebrovascular disease meeting at least 1 of the following criteria:
prior transient ischemic attack with ≥50% carotid stenosis.
internal or external carotid artery stenosis of ≥70% or 2 or more ≥50% stenoses.
prior internal or external carotid artery revascularization.
C. Significant peripheral arterial disease meeting at least 1 of the following criteria:
≥50% stenosis in a limb artery.
history of abdominal aorta treatment (percutaneous and surgical) due to atherosclerotic disease.
ankle brachial index (ABI) \<0.85.
D. Diabetes mellitus with at least 1 of the following:
known microvascular disease, defined by diabetic nephropathy or treated retinopathy. Diabetic nephropathy defined as persistent microalbuminuria (urinary albumin to creatinine ratio ≥30mg/g) and/or persistent estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m\^2 that is not reversible due to an acute illness.
chronic daily treatment with an intermediate or long-acting insulin.
diabetes diagnosis ≥10 years ago.
•At least 1 of the following 1 high-risk criteria (most recent lab values within 6 months prior to screening, as applicable):
Polyvascular disease, defined as coronary, carotid, or peripheral artery stenosis ≥50% in a second distinct vascular location in a participant with coronary, cerebral or peripheral arterial disease (A, B, or C above).
Presence of either diabetes mellitus or metabolic syndrome in a participant with coronary, cerebral, or peripheral artery disease (A, B, or C above).
At least 1 coronary, carotid, or peripheral artery residual stenosis of ≥50% in a participant with diabetes meeting inclusion criterion (D above).
LDL-C ≥130 mg/dL (≥3.36 mmol/L), OR non-HDL-C ≥160 mg/dL (≥4.14 mmol/L), OR apolipoprotein B ≥120 mg/dL (2.3 µmol/L) if available.
Lipoprotein (a) \>125 nmol/L (50 mg/dL).
Known familial hypercholesterolemia.
Family history of premature coronary artery disease defined as an MI or CABG in the participant's father or brother at age \<55 years or an MI or CABG in the participant's mother or sister at age \<60 years.
High sensitive c-reactive protein (hsCRP) ≥3.0 mg/L in the absence of an acute illness.
Current tobacco use.
≥65 years of age.
Menopause before 40 years of age.
eGFR 15 to \<45 mL/min/1.73 m\^2.
Coronary artery calcification score ≥300 in a participant without a coronary revascularization prior to randomization.

Criterios de exclusión

MI or stroke prior to randomization.
CABG ˂ 3 months prior to screening.
eGFR ˂ 15 mL/min/1.73 m\^2.
Uncontrolled or recurrent ventricular tachycardia in the absence of an implantable-cardioverter defibrillator.
Atrial fibrillation or atrial flutter not on anticoagulation therapy (vitamin K antagonist, heparin, low molecular weight heparin, fondaparinux,or non-Vitamin K antagonist oral anticoagulant).
Triglycerides ≥ 500 mg/dL (5.7 mmol/L) measured up to 3 months prior to screening. The most recent results must be used.
Last measured left-ventricular ejection fraction ˂ 30% or New York Heart Association (NYHA) Functional Class III/IV.
Planned arterial revascularization.

Ubicaciones

Instituto de Investigaciones Clinicas Bahia Blanca

Bahía Blanca, Buenos Aires, Argentina

Stat Research

CABA, Buenos Aires, Argentina

Cinme - Centro de Investigaciones Metabolicas

CABA, Buenos Aires, Argentina

Ciprec - Centro de Investigacion y Prevencion Cardiovascular

CABA, Buenos Aires, Argentina

Consultorio Medico Dr Litvak Bruno

CABA, Buenos Aires, Argentina

Centro de Especialidades Medicas - Cemedic

CABA, Buenos Aires, Argentina

Centro Medico Laura Maffei

CABA, Buenos Aires, Argentina

Cardiología Palermo

CABA, Buenos Aires, Argentina

Cedic - Centro de Investigacion Clinica

CABA, Buenos Aires, Argentina

Centro Medico Dra De Salvo

CABA, Buenos Aires, Argentina

Fundacion Respirar

CABA, Buenos Aires, Argentina

Instituto de Investigaciones Metabolicas - Idim

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Hospital Universitario Fundacion Favaloro

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Icba - Instituto Cardiovascular de Buenos Aires

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Glenny Corp SA

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Mar del Plata

Mar del Plata, Buenos Aires, Argentina

Ciad - Consultorio Integral de Atencion al Diabetico

Morón, Buenos Aires, Argentina

Dim Clinica Privada

Ramos Mejía, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas de San Nicolas

San Nicolás de los Arroyos, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Zarate

Zárate, Buenos Aires, Argentina

Clinica Privada del Prado

Córdoba, Córdoba Province, Argentina

Clinica Fusavim Privada SRL

Villa María, Córdoba Province, Argentina

Sanatorio Santa Rosa Srl

Santa Rosa, La Pampa Province, Argentina

Instituto de Investigaciones Clínicas Rosario-Sanatorio Delta

Rosario, Santa Fe Province, Argentina

Sanatorio Plaza

Rosario, Santa Fe Province, Argentina

Centro Modelo de Cardiologia

San Miguel de Tucumán, Tucumán Province, Argentina

Clinical Mayo de Urgencias Medicas Cruz Blanca SRL

San Miguel de Tucumán, Tucumán Province, Argentina

Instituto de Cardiologia de Corrientes Juana Francisca Cabral

Corrientes, Argentina

Instituto Medico DAMIC - Fundacion Rusculleda

Córdoba, Argentina

Cordis Sa

Salta, Argentina

Clinica El Castano

San Juan, Argentina

Instituto Cardiovascular San Luis

San Luis, Argentina

Centro de Investigaciones Clinicas del Litoral

Santa Fe, Argentina

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Impact of Evolocumab on Major Cardiovascular Events in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Evolocumab

Placebo

Ubicaciones

Instituto de Investigaciones Clinicas Bahia Blanca

Stat Research

Cinme - Centro de Investigaciones Metabolicas

Ciprec - Centro de Investigacion y Prevencion Cardiovascular

Consultorio Medico Dr Litvak Bruno

Centro de Especialidades Medicas - Cemedic

Centro Medico Laura Maffei

Cardiología Palermo

Cedic - Centro de Investigacion Clinica

Centro Medico Dra De Salvo

Fundacion Respirar

Instituto de Investigaciones Metabolicas - Idim

Hospital Universitario Fundacion Favaloro

Icba - Instituto Cardiovascular de Buenos Aires

Glenny Corp SA

Instituto de Investigaciones Clinicas Mar del Plata

Ciad - Consultorio Integral de Atencion al Diabetico

Dim Clinica Privada

Instituto de Investigaciones Clinicas de San Nicolas

Instituto de Investigaciones Clinicas Zarate

Clinica Privada del Prado

Clinica Fusavim Privada SRL

Sanatorio Santa Rosa Srl

Instituto de Investigaciones Clínicas Rosario-Sanatorio Delta

Sanatorio Plaza

Centro Modelo de Cardiologia

Clinical Mayo de Urgencias Medicas Cruz Blanca SRL

Instituto de Cardiologia de Corrientes Juana Francisca Cabral

Instituto Medico DAMIC - Fundacion Rusculleda

Cordis Sa

Clinica El Castano

Instituto Cardiovascular San Luis

Centro de Investigaciones Clinicas del Litoral

Patrocinadores