CTRI/2008/091/000018Other3 期
A multicenter, randomized, double-blind, assessor-blind, non-inferiority study comparing the efficacy and safety of once-weekly subcutaneous biotinylated idraparinux (SSR126517E) with adjusted-dose warfarin in the prevention of stroke and systemic thromboembolic events in patients with atrial fibrillation - BOREALIS AF
SanofiSynthelabo India Limited0 个研究点目标入组 9,600 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- Other
- 发起方
- 入组人数
- 9,600
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
入选标准
- •1. Permanent, persistent or paroxysmal non-valvular atrial fibrillation that is ECG-documented
- •2. With an indication for 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 requiring drug treatment; (2) moderately or severely impaired left ventricular function and/or congestive heart failure; (3) age > 75 years; (4) diabetes mellitus
排除标准
- •1. Indication for VKA other than AF, including prosthetic heart valves, venous thromboembolism.
- •2. Stroke within previous 5 days or transient ischemic attack within previous 5 days.
- •3. Transient AF caused by a reversible disorder.
- •4. Planned major surgery or cardioversion within 30 days.
- •5. INR > 3 at baseline.
- •6. Uncontrolled hypertension: systolic blood pressure > 180 mm Hg &/or diastolic blood pressure > 110 mm Hg.
- •7. Active bleeding or high risk of bleeding
- •8. Pregnant or childbearing potential without proper contraceptive measures or breast feeding.
研究者
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