PER-067-08已完成未知
A multicenter, randomized, double-blind, assessor-blind, non-inferiority study comparing the efficacy and safety of once-weekly subcutaneous biotinylated idraparinux (SSR126517E) with oral adjusted-dose warfarin in the prevention of stroke and systemic thromboembolic events in patients with atrial fibrillation - BOREALIS-AF
sanofi-aventis Recherche & Development,0 个研究点目标入组 0 人开始时间: 2008年9月2日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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
- 75 至 90（—）
入选标准
- •Permanent, persistent or paroxysmal non-valvular atrial fibrillation that is documented by an ECG.
- •With an indication of long-term VKA therapy based on the presence of previous ischemic stroke, TIA or systemic embolism and / or at least two of the following risk factors: 1) hypertension that requires treatment with medication; 2) Left ventricular function with moderate or severe damage and / or congestive heart failure; 3) age> 75 years; 4) diabetes mellitus.
- •Informed consent obtained.
排除标准
- •Legal limitations for minority (specific to each country).
- •Indication of VKA other than AF, including prosthetic heart valves, venous thromboembolism.
- •EVC 5 days before or transient ischemic attack within the previous 5 days.
- •Passive AF caused by a reversible disorder.
- •Major planned surgery or cardioversion within 30 days.
- •Participation in another pharmacotherapeutic study within the previous 30 days.
- •Life expectancy <6 months.
- •INR> 3 in the baseline.
- •Active hemorrhage or high risk of bleeding.
- •Hemorrhagic disorder.
- •Major surgery or trauma within the previous 30 days.
- •History of intracranial, intraocular, spinal, evident gastrointestinal, retro peritoneal or intra-articular traumatic hemorrhage or life-threatening hemorrhage.
- •Uncontrolled hypertension: systolic blood pressure> 180 mm Hg and / or diastolic blood pressure> 110 mm Hg
- •Any other contraindication mentioned on the warfarin label (see Appendix D).
- •Pregnancy or ability to procreate without appropriate contraceptive measures
- •Being in breastfeeding period
- •Hypersensitivity to SSR126517E
- •Previous exhibition to idraparinux
- •Basal creatinine clearance <30 mL / min
- •Known allergy to eggs or avidin.
研究者
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