The AMADEUS Trial, A Multicenter, Randomized, Open-label, Assessor Blind, Non-inferiority Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous Idraparinux (SR34006) With Adjusted-dose Oral Vitamin-K Antagonists in the Prevention of Thromboembolic Events in Patients With Atrial Fibrillation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 4,673
- 试验地点
- 86
- 主要终点
- Composite of all strokes and non-CNS systemic embolism.
研究概览
简要总结
This trial will include patients who have a heart condition called atrial fibrillation. Atrial fibrillation is an abnormal rhythm (irregular beat) in the heart. Patients with atrial fibrillation have an increased chance for a blood clot to form in the heart and move to other blood vessels in the body and cause obstruction. This obstruction may damage tissue. For example, a blood clot plugging a vessel in the brain could cause a stroke. Therefore, patients with atrial fibrillation may be given anticoagulant (blood-thinning) tablets such as warfarin or acenocoumarol.
The purpose of this study is to compare the safety and effectiveness of a new injectable anticoagulant drug that is administered once weekly, SR34006 with warfarin or acenocoumarol tablets.
Assignment to either SR34006 Injection or vitamin K antagonist (warfarin or acenocoumarol) tablets will be purely by chance and will be known by both patients and their doctors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECG-documented atrial fibrillation (AF) and an indication for long-term vitamin K antagonist (VKA) therapy based on the presence of at least one of the following risk factors:
- •previous ischemic stroke, transient ischemic attack (TIA) or systemic embolism
- •hypertension requiring drug treatment
- •left ventricular dysfunction (left ventricular ejection fraction <45% or symptomatic congestive heart failure)
- •age >75 years
- •age between 65-75 years plus diabetes mellitus, or
- •age between 65-75 years plus symptomatic coronary artery disease (previous myocardial infarction (MI) or angina pectoris)
- •Written informed consent
排除标准
- •Legal lower age limitations (country specific)
- •Indication for VKA other than AF, including prosthetic heart valves, venous thromboembolism, and planned cardioversion
- •Transient AF caused by a reversible disorder
- •Active bleeding or high risk of bleeding
- •Recent (<15 days) or anticipated invasive procedures with potential for uncontrolled bleeding, including major surgery
- •Participation in another pharmacotherapeutic study within the prior 30 days
- •Creatinine clearance <10 mL/min, severe hepatic disease, or bacterial endocarditis
- •Uncontrolled hypertension: systolic blood pressure > 180 mm Hg and/or diastolic blood pressure > 110 mm Hg
- •Pregnancy or childbearing potential without proper contraceptive measures
- •Breastfeeding
- •Any other contraindication listed in the labeling of warfarin or acenocoumarol
结局指标
主要结局
Composite of all strokes and non-CNS systemic embolism.
次要结局
- Separate components of the primary study outcome.