NCT04262492招募中不适用
OBServaToire INternational Des Patients AnTiphospholipidEs traités Par Anticoagulants Oraux Directs
Stéphane Zuily2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2020年10月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Rate of Recurrent Thrombosis
研究概览
简要总结
This registry, currently being established will ensure consistency of data collection and provide safety information in non high-risk APS patients currently on DOACs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient receiving a comprehensive information about the study, and not opposed to participate
- •Age ≥ 18 yo
- •Classification of definite APS according to revised Sapporo-Sydney criteria
- •Direct oral anticoagulant treatment prescribed during at least 6 months or with the possibility of follow-up of at least 6 months
排除标准
- •Incomplete revised Sapporo-Sydney criteria
- •No data regarding the recurrent thrombosis
- •Pregnant woman
- •Age < 18 yo
结局指标
主要结局
Rate of Recurrent Thrombosis
时间窗: 6 months
Rate of Recurrent Thrombosis either arterial, venous or microvascular confirmed by a relevant exam
次要结局
- Rate of Bleeding(6 months)
- Adherence to treatment(6 months)
- Rate of Non-Criteria Manifestations(6 months)
研究者
Stéphane Zuily
Professor
Central Hospital, Nancy, France
研究点 (2)
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