Patient INR Self-Testing Program Improves the Quality of Oral Anticoagulant Therapy After Mechanical Heart Valve Replacement
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 206
- 主要终点
- Hemorrhagic events and thromboembolic events
研究概览
简要总结
The aims of the study are to prove correlation between laboratory and patient self-testing (PST) measurements, estimation of INR variability within a target therapeutic zone and frequency of hemorrhagic and/or thromboembolic events after mechanical heart valve replacement.
详细描述
This is the first French, prospective, randomised, single centre study, comparing patient self-testing (PST) of international normalised ratio (INR), with conventional laboratory monitoring. Aims of the study are to prove correlation between laboratory and PST measurements, estimation of INR variability within a target therapeutic zone and frequency of hemorrhagic and/or thromboembolic events after mechanical heart valve replacement.
Patients (206) were postoperatively, randomly, consecutively included (2004 - 2008): 103 patients in each group, with a one year follow-up. Two INR control devices were selected: Coaguchek® (Roche) and INRATIO® (Hemosense).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
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
- •patients fitted with one or more mechanical heart valves either alone or in combination with myocardial revascularization
- •oral anticoagulant treatment
- •patients with social security cover
- •written informed consent signed by both patient and investigator
- •able to be followed up during 12 months
排除标准
- •refusal of participation in the study
- •Participation in another clinical study
- •Patient is pregnant or nursing
- •Life expectancy less than three months
- •Contra-indication of to an A.V.K treatment
- •Difficult comprehension of the French language
- •Patients unable to master the self-monitoring procedures
- •Individuals under judicial control or enquiry
- •Patients on dialysis Patients with incomplete understanding of instructions
- •Blind patients and those unable to read
结局指标
主要结局
Hemorrhagic events and thromboembolic events
时间窗: after mechanical heart valve replacement
次要结局
- Correlation of laboratory INR and device INR control(after mechanical heart valve replacement)