Which Decision After a First Venous Thromboembolism? The WHITE Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Number of patients who continue or stop the anticoagulant treatment
研究概览
简要总结
The WHITE study is a multicenter, multinational, investigators-initiated, observational, prospective study conducted in a consecutive series of ambulatory patients who had completed the recommended or practicable period of anticoagulation after a first-ever episode of venous thromboembolism (VTE)
The general aim of the study is to evaluate the distribution of decisions and of the reasons guiding the physician's decision on the modality to manage the secondary prevention of VTE in patients treated for a first-ever episode of VTE, after the initial 3-12 months of anticoagulant therapy.
详细描述
The WHITE study is an international, non-profit, multicenter, observational, prospective and no profit study 3,200 subjects having experienced a first-ever episode of DVT of the lower limbs and/or PE, receive anticoagulation therapy for a period as recommended by international and/or local practice guidelines will be enrolled across all the countries participating to the study.
When this recommended period expires, the attending physician has to decide whether to continue with anticoagulation, switch to anti-thrombotic of another class, or stop any prophylactic pharmacological treatment.
The primary objective of the study is the evaluation of the distribution of decisions and of the reasons guiding the physician's decision on the modality to manage the secondary prevention of VTE in patients treated for a first-ever episode of VTE, after the initial 3-12 months of anticoagulation therapy.
The secondary objective is the collection of data during the follow-up: the frequency of thromboembolic complications, of bleeding complications, or death from any cause.
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
- •subjects who provided a written informed consent and authorization for disclosure of protected health information;
- •male and female adult or elderly patients of any ethnicity having had a first-ever event of provoked or unprovoked DVT of the lower limbs and/or PE and treated with oral anticoagulant
- •for whom the center is in possession of all the data relevant to the index event;
- •having a permanent reference contact.
排除标准
- •subjects <18 years old;
- •subjects unable or unwilling to issue the written informed consent;
- •subjects for whom the information relevant to the index event are incomplete or inaccessible to the Investigator;
- •subject in whom the index event was a DVT not of the lower limbs;
- •subjects with life expectancy of less than 2 years;
- •subjects participating in any other clinical study, regardless of its nature;
- •subjects considered, by the attending physician, unable to comply with the study procedures.
结局指标
主要结局
Number of patients who continue or stop the anticoagulant treatment
时间窗: From the end of the 3rd month to the end of 12th month of anticoagulant treatment
Registration of number of patients who continue or stop the treatment; registration of type reasons guiding the attending physician's decision on the management of secondary prevention (eg: Bleeding score, laboratory test, presence of residual vein trombosis, risk or recurrence)
次要结局
- Frequence of adverse events during follow-up(Frome the first day of enrollment up to 24 monhts)