Resumen

El objetivo primario del estudio es determinar si pemafibrate administrado dos veces al día retrasará el tiempo hasta la primera ocurrencia de cualquier componente del criterio de valoración clínico compuesto de: * infarto de miocardio (IM) no fatal * accidente cerebrovascular isquémico no fatal * revascularización coronaria; o * muerte cardiovascular (CV).

Descripción detallada

Ensayo clínico multinacional con centros participantes en los siguientes países. La India participa bajo una versión anterior del protocolo por requisitos regulatorios. * Argentina * Brasil * Bulgaria * Canadá * Colombia * República Checa * Dinamarca * Francia * Alemania * Hungría * India * Israel * Japón * México * Países Bajos * Polonia * Rumanía * Federación Rusa * Eslovaquia * Sudáfrica * España * Ucrania * Reino Unido * Estados Unidos

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Fasting TG ≥ 200 mg/dL (2.26 mmol/L) and \< 500 mg/dL (5.65 mmol/L) at Visit 1 (Screening/Enrollment Visit) or Visit 1.1 (Retest)
HDL-C ≤ 40 mg/dL (1.03 mmol/L) at Visit 1 (Screening/Enrollment Visit) or Visit 1.1 (Retest)
Type 2 diabetes of longer than 12 weeks duration documented in medical records, for example: local laboratory evidence through medical record review of elevated HbA1c (≥ 6.5% \[48 mmol/mol\]), elevated plasma glucose (fasting ≥ 126 mg/dL \[7.0 mmol/L\], 2-hour ≥ 200 mg/dL \[11.1 mmol/L\] during oral glucose tolerance testing, or random value ≥ 200 mg/dL with classic symptoms, or currently taking medication for treatment of diabetes; AND either
Age ≥ 50 years if male or ≥ 55 years if female (primary prevention cohort); OR
Age ≥ 18 years and established systemic atherosclerosis (secondary prevention cohort), defined as any 1 of the following:
i. Prior MI or ischemic (non-hemorrhagic) stroke
ii. Coronary angiographic lesion of ≥ 60% stenosis in a major epicardial vessel or ≥ 50% left main stenosis
iii. Asymptomatic carotid disease with ≥ 70% carotid artery stenosis
iv. Symptomatic carotid disease with ≥ 50% carotid artery stenosis
v. Symptomatic lower extremity PAD (ie, intermittent claudication, rest pain, lower extremity ischemic ulceration, or major amputation with either ankle-brachial index ≤ 0.9 or other diagnostic testing \[eg, toe-brachial index, angiogram, or other imaging study\])
vi. Prior arterial revascularization procedure (including coronary, carotid, or peripheral angioplasty/stenting, bypass, or atherectomy/endarterectomy)

Criterios de exclusión

Current or planned use of fibrates or agents with PPAR-α agonist activity (eg, saroglitazar) within 6 weeks (42 days) of Visit 1 (Screening/Enrollment Visit). Note: PPAR-γ agonists (eg, glizatones such as pioglitazone and rosiglitazone) are allowed
Known sensitivity to PPAR-α agonists or tablet excipients
Initiation of, or change in, current TG-lowering therapy within 12 weeks of Visit 1 (if applicable). Note: TG-lowering therapy is defined as niacin \> 100 mg/day or dietary supplements or prescription omega-3 fatty acids \> 1 g/day
Type 1 diabetes mellitus

Ubicaciones

Hospital Interzonal General de Agudos Dr Jose Penna

Bahía Blanca, Buenos Aires, Argentina

Hospital Italiano Regional del Sur

Bahía Blanca, Buenos Aires, Argentina

Hospital Italiano

Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

CICLO

La Plata, Buenos Aires, Argentina

Centro de Investigaciones Medicas Mar del Plata

Mar del Plata, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas

Mar del Plata, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas San Nicolas

San Nicolás de los Arroyos, Buenos Aires, Argentina

Instituto Clinico Metabolico

San Nicolás de los Arroyos, Buenos Aires, Argentina

Clinica Olivos

Vicente López, Buenos Aires, Argentina

Centro Medico Viamonte SRL

Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina

Hospital Sirio Libanes

Caba, Ciudad Autonoma Buenos Aires, Argentina

Sanatorio Güemes

Ciudad Autonoma de Bs. As., Ciudad Autonoma Buenos Aires, Argentina

CEMEDIC - Centro de Especialidades Medicas

Villa Luro, Ciudad Autonoma Buenos Aires, Argentina

Centro Medico Luquez

San Vicente, Córdoba Province, Argentina