Ensayo aleatorizado, doble ciego, controlado con placebo,... | EligiMed

Ensayo aleatorizado, doble ciego, controlado con placebo, de grupos paralelos, multinacional, para evaluar la prevención de eventos trombóticos con ticagrelor en comparación con placebo sobre un tratamiento de base con ácido acetilsalicílico (AAS) en pacientes con antecedente de infarto de miocardio

CompletadoFase 3ClinicalTrials.gov

ID: NCT01225562Tipo: INTERVENTIONALInicio: 1 de oct de 2010Fin estimado: 1 de dic de 2014

Resumen

Este estudio se lleva a cabo para evaluar si un nuevo fármaco llamado ticagrelor, administrado dos veces al día además del tratamiento con AAS, disminuye la frecuencia de eventos cardiovasculares (por ejemplo, muerte por enfermedad cardíaca, infarto de miocardio o accidente cerebrovascular).

Elegibilidad

Edad mínima: 50 YearsEdad máxima: 130 YearsSexo: ALL

Criterios de inclusión

Person who had a heart attack within 1 - 3 years ago and at least one additional risk factor: Age ≥ 65 years old, Diabetes requiring medication, Documented history of 2nd prior MI (\>1 year ago). Angiographic evidence of multivessel CAD, and / or Chronic, non-end stage renal dysfunction.
Females of child-bearing potential must have a negative pregnancy test at enrollment
Persons who are currently taking aspirin between 75 and 150 mg once daily

Criterios de exclusión

Persons who are being treated with agents inhibiting blood clotting if the agent cannot be stopped at study start
Persons who have planned coronary, cerebrovascular, or peripheral arterial Revascularization (invasive surgery) at study start
Persons with known bleeding disorders
Persons who need chronic oral anticoagulant therapy or chronic low-molecular-weight heparin
Persons with a history of ischemic stroke
Persons with a history of intracranial bleeding at any time, a tumor or blood vessel abnormality in the brain and/or spinal cord at any time, a history of surgery involving the brain or spinal cord within the last 5 years, or a history of bleeding from the gastrointestinal tract (eg, esophagus, stomach, colon, rectum) within the last 6 months or a major surgery within the last 30 days.
Persons considered to be at risk of bradycardic events unless already treated with a permanent pacemaker
Persons who have had open heart surgery within the past 5 years, unless the person had a heart attack after the surgery
Persons with known severe liver disease
Persons with kidney failure requiring dialysis
Persons with life expectancy \< 1 year

Intervenciones

drug

Ticagrelor 90 mg

Oral dose twice a day

drug

Ticagrelor 60 mg

Oral dose twice a day

drug

Ticagrelor Placebo

Oral dose twice a day

Ubicaciones

Research Site

Bahía Blanca, Argentina

Research Site

Buenos Aires, Argentina

Research Site

Ciudad Autonoma de BA, Argentina

Research Site

Ciudad de Buenos Aires, Argentina

Research Site

Ciudadela, Argentina

Research Site

Coronel Suárez, Argentina

Research Site

Corrientes, Argentina

Research Site

Córdoba, Argentina

Research Site

Haedo, Argentina

Research Site

La Plata, Argentina

Research Site

Mar del Plata, Argentina

Research Site

Ramos Mejía, Argentina

Research Site

Rosario, Argentina

Research Site

Rosario Santa Fe, Argentina

Research Site

San Luis, Argentina

Research Site

San Miguel de Tucumán, Argentina

Research Site

San Nicolás, Argentina

Research Site

San Salvador de Jujuy, Argentina

Research Site

Santa Fe, Argentina

Research Site

Santa Fé, Argentina

Research Site

Zárate, Argentina

Patrocinadores

PrincipalAstraZeneca

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