ACTRN12609000026224招募中3 期
A Phase 3, Active (Warfarin) Controlled, Randomized,Double-Blind, Parallel Arm Study to Evaluate Efficacy and Safety of Apixaban inPreventing Stroke and Systemic Embolism in Subjects with Nonvalvular AtrialFibrillation
Bristol-Myers Squibb Australia0 个研究点目标入组 15,000 人开始时间: 2009年1月15日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Males and females = 18 yrs with Atrial Fibrillation and one or more of the following risk factors for stroke:
- •- Age = 75, previous stroke
- •- Transient Ischemic Attack (TIA) or Systemic Embolism
- •- Symptomatic congestive heart failure or left ventricular dysfunction with Left Ventricular Ejection Fraction (LVEF) = 40%
- •- Diabetes mellitus or hypertension requiring pharmacological treatment
排除标准
- •- Atrial fibrillation or flutter due to reversible causes (e.g. thyrotoxicosis, pericarditis)
- •- Clinically significant (moderate or severe) mitral stenosis
- •- Increased bleeding risk that is believed to be a contraindication to oral anticoagulation (e.g. previous intracranial hemorrhage)
- •- Conditions other than atrial fibrillation that require chronic anticoagulation (e.g.
- •prosthetic mechanical heart valve)
- •- Persistent, uncontrolled hypertension (systolic Blood Pressure (BP) > 180 mm Hg, or diastolic BP
- •> 100 mm Hg)
- •- Planned major surgery
- •- Planned atrial fibrillation or flutter ablation procedure
- •- Required treatment with aspirin > 165 mg/day
- •- Recent ischemic stroke (within 7 days)
研究者
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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 Subjects with Nonvalvular Atrial Fibrillation + Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific, version 3.0, dated 04-Nov-2006Revised protocol 04 incorporating amendments 02, 05, 07, 10 & 11 and administrative letters 02, 04, 05 & 08 - ARISTOTLETHROMBOSISMedDRA version: 9.1Level: LLTClassification code 10003658Term: Atrial fibrillationMedDRA version: 9.1Level: LLTClassification code 10057613Term: Thromboembolic strokeARRHYTHMIAEUCTR2006-002147-91-ATBristol Myers Squibb International Corporation18,000
进行中（未招募）
不适用
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 Subjects with Nonvalvular Atrial Fibrillation + Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific, version 3.0, dated 04-Nov-2006Revised protocol 04 incorporating Amendments 02, 05, 07, 10 & 11 and Administrative letters 02, 04, 05 & 08 - ARISTOTLEARRHYTHMIAEUCTR2006-002147-91-FIBristol Myers Squibb International Corporation18,000
进行中（未招募）
1 期
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 Subjects with Nonvalvular Atrial Fibrillation Revised Protocol 02 (incorporating Protocol Amendments 02 & 07, and Administrative Letter 02) + Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific, version 3.0, dated 04-Nov-2006 + Admin Letter Number 1 , version 1.0 dated 27-Feb-2007 + Amendment Number 5, version 1.0, dated 17-Nov-2007 - ARISTOTLEARRHYTHMIAEUCTR2006-002147-91-GBBristol Myers Squibb International Corporation18,000
进行中（未招募）
不适用
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 Subjects with Nonvalvular Atrial Fibrillation + Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific, version 3.0, dated 04-Nov-2006Revised protocol 04 incorporating amendments 02, 05, 07, 10 & 11 and administrative letters 02, 04, 05 & 08 - ARISTOTLETHROMBOSISMedDRA version: 9.1Level: LLTClassification code 10003658Term: Atrial fibrillationMedDRA version: 9.1Level: LLTClassification code 10057613Term: Thromboembolic strokeARRHYTHMIAEUCTR2006-002147-91-SEBristol Myers Squibb International Corporation18,000
已完成
不适用
Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation ARISTOTLE-I48 Atrial fibrillation and flutterAtrial fibrillation and flutterI48PER-099-08BRISTOL MYERS SQUIBB COMPANY,