NL-OMON35379已完成3 期
Protocol CV185030: A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel-Arm Study to Evaluate Efficacy and Safety of Apixaban In Preventing Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation - ARISTOTLE
Bristol-Myers Squibb0 个研究点目标入组 252 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 252
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
- •1) Age >= 18 years
- •2) In atrial fibrillation or atrial flutter not due to reversible cause and documented by ECG at the time of enrollment OR If not in atrial fibrillation/flutter at the time of enrollment, must have atrial fibrillation/flutter documented on two separate occasions, not due to a reversible cause at least 2 weeks apart in the 12 months prior to enrollment.
- •3) One or more of the following risk factor(s) for stroke: a) Age 75 years or older, b) prior stroke, TIA or systemic embolus, c) Either symptomatic congestive heart failure within 3 months or left ventricular dysfunction with an LV ejection fraction (LVEF) <= 40%, d) Diabetes mellitus, e) hypertension requiring pharmacological treatment.
排除标准
- •1) Atrial fibrillation or flutter due to reversible causes.
- •2) Clinically significant mitral stenosis
- •3) Increased bleeding risk that is believed to be a contraindication to oral anticoagulation.
- •4) Conditions other than atrial fibrillation that require chronic anticoagulation.
- •5) Persistent, uncontrolled hypertension (systolic BP > 180 mmHg of diastolic BP > 100 mm Hg).
- •6) Active infective endocarditis.
研究者
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Protocol Title: A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind,Parallel Arm Study to Evaluate Efficacy and Safety of Apixaban in Preventing Strokeand Systemic Embolism in Subjects with Nonvalvular Atrial Fibrillation - ARISTOTLEArrhythmiaEUCTR2006-002147-91-ITBristol_myers Squibb International Corporation15,000
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