NL-OMON35625已完成3 期
A Prospective, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter, Event-Driven, Non-inferiority Study Comparing the Efficacy and Safety of Once Daily Oral Rivaroxaban (BAY 59-7939) With Adjusted-Dose Oral Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation (39039039AFL3001) - ROCKET-AF
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Adult subjects with non valvular atrial fibrillation and prior stroke, TIA or non CNS systemic embolism or who have 2 or more of the following risk factors: age >_75 years, hypertension, heart failure and/or left ventricular ejection fraction <_35% or diabetes mellitus.
排除标准
- •Patients with cardiac-related conditions, hemorrhage risk-related criteria and concomitant conditions and therapies that will have an impact on the wellbeing of the patient when used simultaneously with the studymedication.
研究者
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A Prospective, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter, Event-Driven, Non-inferiority Study Comparing the Efficacy and Safety of Once Daily Oral Rivaroxaban (BAY 59-7939) With Adjusted-Dose Oral Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation (39039039AFL3001)EUCTR2006-004595-13-GRBayer HealthCare AG14,000
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A Prospective, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter, Event-Driven, Non-inferiority Study Comparing the Efficacy and Safety of Once Daily Oral Rivaroxaban (BAY 59-7939) With Adjusted-Dose Oral Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation (39039039AFL3001) Estudio Prospectivo, Aleatorizado, Doble ciego, con Doble Enmascaramiento, de Grupos Paralelos, Multicéntrico, Basado en Acontecimientos, de No Inferioridad para Comparar la Eficacia y Seguridad de Rivaroxaban (BAY 59-7939) oral una vez al día con Warfarina Oral en Dosis Ajustadas para la Prevención del Accidente Cerebro Vascular y la Embolia Sistémica Periférica en Sujetos con Fibrilación Auricular no ValvularPrevention of Stroke and Non-CNS Systemic Embolism in Non-Valvular Atrial Fibrillation Prevención del Accidente Cerebro Vascular y la Embolia Sistémica Periférica en Fibrilación Auricular no ValvularMedDRA version: 8.1 Level: LLT Classification code 10003658 Term: Atrial fibrillationEUCTR2006-004595-13-ESBayer HealthCare AG
已完成
3 期
An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial FibrillatioCTRI/2009/091/000201Bayer HealthCare AG14,266