Follow-up in Rivaroxaban Patients in Setting of Thromboembolism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,343
- 试验地点
- 4
- 主要终点
- Incidence of long term complications
研究概览
简要总结
In patients with acute clots (deep vein thrombosis or pulmonary embolism) the investigators will collect real world data on their short and long term outcomes. The investigators hypothesise that in patients treated from the outset with rivaroxaban that: 1. treatment will be non-inferior to treatment with conventional anticoagulants (heparins and warfarin); 2. there will be less bleeding than when patients are on conventional anticoagulants; 3. there will be a lower long-term incidence of morbidity from chronic thromboembolic pulmonary hypertension and post-thrombotic limb syndrome.
详细描述
United Kingdom-only prospective, non-interventional, investigator-led, multi-centre, single cohort, registry. The observation period for each patient covers the treatment period with rivaroxaban and follow up until study end. For each patient, the treating health care professional records patient demographics, medical history, signs and symptoms, diagnosis, treatment and safety parameters at an initial visit and subsequent follow-up visit(s). Data monitoring will be undertaken by the Sponsor.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or older with an objectively verified diagnosis of DVT and/or PE and treated according to routine clinical practice with Rivaroxaban
排除标准
- •Patients in whom follow-up is unlikely or impossible
- •Patients unable to give consent
- •Patients who receive heparin therapy for more than 48 hours
- •Patients who receive more than one dose of warfarin
- •Patients with an indication for anticoagulation other than DVT and/or PE
- •All contraindications listed in the local product information (SmPC) will form part of the exclusion criteria
结局指标
主要结局
Incidence of long term complications
时间窗: 5 years from diagnosis of index event (DVT or PE), annual follow-up
Incidence of long term complications as composite primary end point of VTE recurrence, PTS and CTEPH in patients treated with rivaroxaban without bridging heparin therapy
次要结局
- Treatment adherence(Full duration of anticoagulation treatment (average of 6 months))
- Quality of life assessment(Full duration of anticoagulation treatment (average of 6 months))
- Incidence of other thromboembolic events(5 years from diagnosis of index event (DVT or PE), annual follow-up)
- Incidence of major post-thrombotic complications(5 years from diagnosis of index event (DVT or PE), annual follow-up)
- Healthcare resource utilisation(Full duration of anticoagulation treatment (average of 6 months))
- Incidence of treatment-emergent bleeding rates(5 years from diagnosis of index event (DVT or PE), annual follow-up)
- All-cause mortality(5 years from diagnosis of index event (DVT or PE), annual follow-up)