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
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 3,773
- 试验地点
- 538
- 主要终点
- Composite of all fatal or non-fatal strokes or non central nervous system (CNS) systemic embolic events (SE)
研究概览
简要总结
The objective is to evaluate whether once weekly subcutaneous (SC) injection of idrabiotaparinux sodium (biotinylated idraparinux) is at least as efficient to prevent clots in brain and in the other organs than oral international normalized ratio (INR) adjusted-dose warfarin in patients with atrial fibrillation (AF).
详细描述
The end of the study is defined by a common study end date for all participants, defined as 9 months (39 weeks) after the last participant randomized.
All participants will receive oral warfarin (or matching placebo) and weekly SC injections of idrabiotaparinux sodium (or matching placebo) up to 6 months before the common study end date. All participants are expected to be treated for at least 6 months.
All participants will have then an 6-month observational period after cessation of study treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Non valvular atrial fibrillation (AF)
- •Indication for long-term Vitamin-K antagonist (VKA) therapy based on the presence of previous ischemic stroke, transient ischemic attack (TIA) or systemic embolism and/or at least two of the following risk factors: hypertension requiring drug treatment, moderately or severely impaired left ventricular function and/or congestive heart failure, age > or = 75 years, diabetes mellitus.
- •Main exclusion Criteria:
- •Indication for VKA other than AF
- •Stroke or TIA within previous 5 days
- •Transient AF caused by a reversible disorder
- •Planned major surgery/trauma or cardioversion within 30 days
- •INR > 3 at baseline
- •Active bleeding or high risk of bleeding
- •Uncontrolled hypertension
- •Pregnancy or childbearing potential without proper contraceptive measures or breast feeding.
排除标准
- 未提供
研究组 & 干预措施
Idrabiotaparinux
Idrabiotaparinux sodium, 3.0 mg, once-weekly for 7 weeks followed a maintenance dosing adjusted according to the age and to the renal function for a minimum total treatment duration of 6 months.
Avidin, 100 mg, at the discretion of the investigator whenever deemed appropriate and possible (ie, life-threatening bleeding, emergency invasive procedure with the potential of uncontrolled bleeding, or overdosage).
干预措施: Idrabiotaparinux sodium (Drug)
Idrabiotaparinux
Idrabiotaparinux sodium, 3.0 mg, once-weekly for 7 weeks followed a maintenance dosing adjusted according to the age and to the renal function for a minimum total treatment duration of 6 months.
Avidin, 100 mg, at the discretion of the investigator whenever deemed appropriate and possible (ie, life-threatening bleeding, emergency invasive procedure with the potential of uncontrolled bleeding, or overdosage).
干预措施: Placebo (for warfarin) (Drug)
Idrabiotaparinux
Idrabiotaparinux sodium, 3.0 mg, once-weekly for 7 weeks followed a maintenance dosing adjusted according to the age and to the renal function for a minimum total treatment duration of 6 months.
Avidin, 100 mg, at the discretion of the investigator whenever deemed appropriate and possible (ie, life-threatening bleeding, emergency invasive procedure with the potential of uncontrolled bleeding, or overdosage).
干预措施: Avidin (Drug)
Warfarin
Warfarin, INR-adjusted dose, for a minimum total treatment duration of 6 months.
干预措施: Warfarin (Drug)
Warfarin
Warfarin, INR-adjusted dose, for a minimum total treatment duration of 6 months.
干预措施: Placebo (for idrabiotaparinux) (Drug)
Warfarin
Warfarin, INR-adjusted dose, for a minimum total treatment duration of 6 months.
干预措施: Placebo (for avidin) (Drug)
结局指标
主要结局
Composite of all fatal or non-fatal strokes or non central nervous system (CNS) systemic embolic events (SE)
时间窗: From randomization up to the end of the treatment period (minimum of 6 months)
次要结局
- Components of the primary study outcome measure:(From randomization up to the end of the treatment period (minimum of 6 months))
- Composite of stroke or non CNS SE or myocardial infarction (MI) or venous thromboembolism (VTE) or major bleeding or death(From randomization up to the end of the treatment period (minimum of 6 months))