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
SanofiSynthelabo India Limited1 个研究点 分布在 1 个国家目标入组 9,600 人开始时间: 2008年2月13日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- Other
- 发起方
- 入组人数
- 9,600
- 试验地点
- 1
- 主要终点
- composite of all strokes or non central nervous system (CNS) systemic embolic events (SE)
研究概览
简要总结
Trial will be conducted in 48 countries all over the world The Indian target - 94 patients Indian status - No patients randomized till date Planned date of first enrolment - 28th Feb 2008
A total of 3773 patients were randomized globally. In India, study was initiated at 18 study centers; and 72 patients were enrolled at these centers.
This study has been prematurily terminated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Permanent, persistent or paroxysmal non-valvular atrial fibrillation that is ECG-documented
- •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
- •Indication for VKA other than AF, including prosthetic heart valves, venous thromboembolism.
- •Stroke within previous 5 days or transient ischemic attack within previous 5 days.
- •Transient AF caused by a reversible disorder.
- •Planned major surgery or cardioversion within 30 days.
- •INR > 3 at baseline.
- •Uncontrolled hypertension: systolic blood pressure > 180 mm Hg &/or diastolic blood pressure > 110 mm Hg.
- •Active bleeding or high risk of bleeding
- •Pregnant or childbearing potential without proper contraceptive measures or breast feeding.
结局指标
主要结局
composite of all strokes or non central nervous system (CNS) systemic embolic events (SE)
时间窗: End of study
次要结局
- separate components of the primary study outcome(end of study)
研究者
研究点 (1)
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