Early Glycoprotein IIb/IIIa Inhibition in Non-ST-segment Elevation Acute Coronary Syndrome: A Randomized, Placebo-Controlled Trial Evaluating the Clinical Benefits of Early Front-loaded Eptifibatide in the Treatment of Patients With Non-ST-segment Elevation Acute Coronary Syndrome (EARLY ACS)
Eptifibatide (Integrilin)
+ Placebo
Enfermedades Oclusivas Arteriales+15
+ Enfermedad de las arterias coronarias
+ Angina de Pecho
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de noviembre de 2004
Fecha en la que se inscribió al primer participante.This study will enroll patients who experience symptoms of acute coronary syndrome (experiencing chest pain at rest with episodes lasting at least 10 minutes) and who are planned to undergo invasive surgical procedures after being given study drug for 12 to 96 hours. There are two different treatment groups in this study; approximately half of the patients will go to each group and the likelihood of receiving study drug vs. placebo is 50/50 (like tossing a coin). Medications that are standard of care will be provided to the patients (all patients will be given aspirin and standard hospital doses of one of two other blood thinning drugs - unfractionated heparin (UFH) or low-molecular-weight heparin). Which one patients receive is at the discretion of the Investigator.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 9406 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: * Willing and able to give informed consent and comply with study procedures and follow-up through 1 year. * Plan to undergo an invasive strategy after receiving study drug for 12 to 96 hours. * Able to be randomized into the trial within 12 hours of having symptoms of acute coronary syndrome. * Experiencing symptoms of cardiac ischemia at rest (angina or anginal equivalent) with episode(s) lasting at least 10 minutes and have at least 2 of the following: * 60 years of age or more * Electrocardiogram changes (ECG) * Elevated troponin (protein released in the blood stream in people suffering from acute coronary syndrome) or CK-MB levels * Or have all 3 of the following: * Prior history of cardiovascular disease * Elevated troponin or CK-MB levels * 50-59 years of age Exclusion Criteria: * pregnancy (known or suspected) * renal dialysis within 30 days prior to randomizing in study * other serious illnesses or any condition that the investigator feels would pose a significant hazard to the patient if the investigational therapy was to be initiated * Stroke (hemorrhagic stroke at any time or non-hemorrhagic stroke within previous 7 days), central nervous system damage (such as neoplasm, aneurysm, intracranial surgery), bleeding disorders (including gastrointestinal bleeding), or recent major surgery or major trauma. * History of certain hematologic problems following treatment with heparin or eptifibatide. * Therapy with certain related drugs within a short time before randomization into the trial.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
50% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
PlaceboObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios