Anticoagulant Clinic-based Shared-care Versus Usual Cate Management of Vitamin K Antagonist Therapy : the Open, Randomized Multicenter Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,006
- 试验地点
- 5
- 主要终点
- Each patient is contacted by standardized telephone calls every three months to determine whether he/she has experienced any thromboembolic or major bleeding complication, and to identify any interruptions in VKA treatment
研究概览
简要总结
Background: Whether the management of vitamin K antagonists (VKA) therapy by general practitioners with the collaboration of anticoagulation clinics (ACC) provides better clinical outcomes than that accomplished by general practitioners alone (usual care [UC] management) is not clear.
Objectives: To compare ACC-based shared-care management with UC management of VKA therapy with respect to clinical events.
Patients/Methods: Open, randomized, multicenter study in patients starting VKA therapy for at least three months. The primary study outcome is a composite of confirmed symptomatic thromboembolic or major bleeding events. All-cause mortality is a secondary outcome. All outcomes are reviewed by a central, independent adjudication committee.
详细描述
Study design
The COMPARE (Comparison of Oral anticoagulation Monitoring Practice: A Randomized Evaluation) study is an open, centrally randomized, multicenter, prospective, controlled study comparing two models of vitamin K antagonist (VKA) therapy management. Written informed consent is obtained from each patient and general practitioner before randomization.
Setting and participants
The study concerned patients referred to the anticoagulation clinic (ACC) of various University Hospitals in France. Eligible patients are consecutive patients who were starting a course of VKA therapy scheduled to last for at least three months.
Randomization and interventions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •inpatients and outpatients who are starting a course of VKA therapy scheduled to last for at least three months
排除标准
- •life expectancy of less than three months
- •contraindication to anticoagulant therapy because of bleeding risk
- •refusal of his/her general practitioner to participate in the study
- •no general practitioner likelihood of poor follow-up or poor compliance (e.g., patients unable to care for themselves, lacking adequate home support or unwilling to comply with the treatment care plan)
研究组 & 干预措施
ACC group
Anticoagulant clinic-based shared-care group
干预措施: Anticoagulant (warfarin, acenocoumarol, fluindione) (Drug)
UC group
Usual care group
干预措施: Anticoagulant (warfarin, acenocoumarol, fluindione) (Drug)
结局指标
主要结局
Each patient is contacted by standardized telephone calls every three months to determine whether he/she has experienced any thromboembolic or major bleeding complication, and to identify any interruptions in VKA treatment
时间窗: Patients are followed up for the duration of VKA treatment until 12 months or plus three days after treatment discontinuation
次要结局
- Quality of anticoagulation control evaluated in all patients with at least two INR measurements and assessed by determining (1) the percentage of INR within the target range, (2) the percentage of time during which the INR is within the target range(Patients are followed up for the duration of VKA treatment until 12 months or plus three days after treatment discontinuation.)