Monitoring Anticoagulant Therapy With Vitamin-K Antagonists in Patients With Antiphospholipid Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Difference between INR and CFX correlate >20%
研究概览
简要总结
To Assess the Influence of Antiphospholipid Antibodies on INR Test Results in Patients with the Antiphospholipid Syndrome Anticoagulated with Vitamin-K Antagonists.
详细描述
Patients with an antiphospholipid syndrome receiving Vitamin-K antagonists for secondary prevention after a first thrombotic complication are known to be at higher risk of recurrent thrombotic events despite INR values in the therapeutic range. It ist also known that antiphospholipid antibodies can interfere with phospholipid-dependent tests (e.g. prothrombin time and INR).
The primary objective of this study is to determine the prevalence of interfering antiphospholipid antibodies. The intensity of anticoagulant therapy was assessed by measuring the INR using different thromboplastins and the CoaguChek system for INR self-assessment. Test results were compared to measurements of the phospholipid-independent chromogenic factor X.
The second objective of this study is to evaluate the incidence of recurrent thrombotic events during 1-year follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-90 years
排除标准
- 未提供
结局指标
主要结局
Difference between INR and CFX correlate >20%
时间窗: 0, 1, 2, 3, 6 and 12 month
次要结局
- Arterial or venous thrombosis(12 months)
研究者
Birgit Linnemann
Priv.-Doz. Dr. Birgit Linnemann
Johann Wolfgang Goethe University Hospital