A Double-blind, Randomized, Multi-center, Placebo-controlled, Parallel-group Study to Determine the Effects of Evolocumab (AMG 145) Treatment on Atherosclerotic Disease Burden as Measured by Intravascular Ultrasound in Subjects Undergoing Coronary Catheterization

CompletadoFase 3ClinicalTrials.gov

ID: NCT01813422Tipo: INTERVENTIONALInicio: 18 de abr de 2013Fin estimado: 29 de jul de 2016

Traducción no disponible, mostrando original

Resumen

This study will evaluate whether low-density lipoprotein (LDL-C) lowering with evolocumab (AMG 145) results in greater change from baseline in percent atheroma volume (PAV) at week 78 than placebo in adults with coronary artery disease taking lipid lowering therapy.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 99 YearsSexo: ALL

Criterios de inclusión

Clinical indication for coronary angiography
Subjects already taking statin therapy, niacin or ezetimibe at screening must have been on a stable dose for at least 4 weeks prior to screening LDL-C. Subjects not taking lipid-regulating therapy must enter the study via a lipid stabilization period. Subjects who are intolerant to statins must meet statin intolerance entry criteria
Fasting LDL-C ≥ 80 mg/dL (2.07 mmol/L) with or without additional risk factors, or, LDL-C ≥ 60 -\< 80 mg/dL (1.55-2.07 mmol/L) in the presence of one major or three minor risk factors
Subjects must meet the following criteria at the qualifying coronary catheterization procedure:
Evidence of coronary heart disease (at least one lesion in a native coronary artery that has \> 20% reduction in lumen diameter) or prior percutaneous intervention (PCI)
Left main coronary artery \< 50% reduction in lumen diameter by visual estimation
Target coronary artery for IVUS must be accessible to the IVUS catheter, must not have a \> 50% reduction in lumen diameter within the target segment (and at least 40 mm in length); cannot have undergone prior PCI or coronary artery bypass graft (CABG) and is not a candidate for intervention over the next 18 months. It may not be a bypass graft, bypassed vessel or culprit vessel for previous myocardial infarction (MI).

Criterios de exclusión

Coronary artery bypass graft surgery \< 6 weeks prior to the qualifying IVUS
New York Heart Association (NYHA) III or IV heart failure, or last known left ventricular ejection fraction less than 30%
Uncontrolled cardiac arrhythmia that is not controlled by medications in the 3 months prior to randomization
Known hemorrhagic stroke
Uncontrolled hypertension at randomization
Fasting Triglycerides ≥ 400 mg/dL (4.5 mmol/L) at screening
Type 1 diabetes or poorly controlled type 2 diabetes (hemoglobin A1c \[HbA1c\] \> 9%) at screening.
Moderate to severe renal dysfunction (estimated glomerular filtration rate \[eGFR\] \< 30 ml/min/1.73m²) at screening.

Intervenciones

biological

Evolocumab

Administered by subcutaneous injection

drug

Placebo

Administered by subcutaneous injection

Ubicaciones

Research Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Research Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Research Site

La Plata, Buenos Aires, Argentina

Research Site

Córdoba, Córdoba Province, Argentina

Research Site

Córdoba, Córdoba Province, Argentina

Research Site

Rosario, Santa Fe Province, Argentina

Research Site

Buenos Aires, Argentina

Research Site

Corrientes, Argentina

Research Site

Córdoba, Argentina

Patrocinadores

PrincipalAmgen

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