Comparison of Accidents and Their Circumstances With Oral Anticoagulants. The CACAO Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4,162
- 试验地点
- 3
- 主要终点
- Clinical characteristics
研究概览
简要总结
Differences in efficacy and safety between new oral anticoagulants (NOAC) and vitamin K antagonist (VKA) in real practice remain uncertain.
The few existing ambulatory studies did not answer all NOAC specific issues, such as prescription habits and motives, patients characteristics, biological monitoring, as well as the occurrence of major and minor thromboembolic events, especially in France where warfarin is less frequently prescribed.
Therefore, in order to describe clinical and follow up characteristics of patients receiving oral anticoagulants, the investigators will set up a national prospective cohort to compare the occurrence of thromboembolic events between VKA and NOAC in primary care.
详细描述
The method includes the use of a national prospective observational cohort, involving 444 general practitioners From april to december 2014, health data of any adult patient consulting a general practitioner and receiving an oral anticoagulant treatment has been entered in a database. Each patient received an information for agreement to participate to the study (agreement for stastical analysis of their health data during one year follow up).
In March 2015, half of those patients will be chosen (stratification), using a matched stratification process, and will be followed up over one year. Every three months, data regarding the occurrence of therapeutics changes, episodes of excessive bleeding, and thromboembolic events will be collected by general practitioners.
The data will be analysed by: - describing the characteristics of patients receiving oral anticoagulant treatment; - describing the changes of medications over the year ; - comparing the occurrence of episodes of excessive bleeding ; - comparing the occurrence of thromboembolic events in patients using VKA versus patients using NOAC.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Clinical characteristics
时间窗: at baseline
The profile of patients receiving VKA or NOAC will be described by the following variables: * Molecule, duration, dosage * Indication: Atrial fibrillaton valvular or not / DVT / PE / Other, Prevention / Treatment * Age, sex, weight, height * Medication adherence ( as perceived by the GP ) * Renal function * CHA2DS2-VASc Score * HAS-BLED Score * RIETE score * unstable INR * Comorbidities: anemia, diabetes, kidney disease, liver disease, hypertension, heart failure, stroke, peripheral vascular desease, myocardial infarction (MI). * Concomitant treatments: NSAIDs, antiplatelets, other treatments with potentials interactions
次要结局
- Therapeutic classes(at baseline, 3, 6, 9 and 12 months)
- Bleeding score(at baseline, 3, 6, 9 and 12 months)
- Bleeding events(at baseline, 3, 6, 9 and 12 months)
- Thrombotic events(at baseline, 3, 6, 9 and 12 months)
- Death(at baseline, 3, 6, 9 and 12 months)