Global Anticoagulant Registry in the Field Observing Treatment and Outcomes in Patients With Treated Acute Venous Thromboembolic Events in the Real World
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10,679
- 试验地点
- 1
- 主要终点
- Hospitalization
研究概览
简要总结
The protocol is a large registry to describe acute, sub-acute and extended duration of anticoagulation management, clinical and economic duration of anticoagulation management, clinical and economic outcomes in patients with treated acute VTE (DVT and PE) in the real-world setting.
Main objectives are to clarify the:
- treatment related details for acute VTE (either conventional anticoagulation therapy, treatment with a direct oral anti-coagulant or other modalities of treatment)
- Rate of early and late symptomatic VTE recurrence
- Rate and nature of complications of VTE including post thrombotic syndrome and chronic thromboembolic pulmonary hypertension
- Rate of bleeding complications
- Rate of all-cause mortality at six months
详细描述
Other objectives are to clarify the additional outcomes of:
- Stroke (Measured by number of incidences)
- Transient Ischemic Attack (TIA) (Measured by number on incidences)
- ST Elevated Myocardial Infarction (STEMI) (Measured by number of incidences)
- Non-ST Elevated Myocardial Infraction (NSTEMI) (Measured by number of incidences)
- Unstable Angina (Measured by number of incidences)
- Quality of life and patient reported outcomes and costs associated with the management of VTE.
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
- •Written informed consent
- •Age 18 years and over
- •Treated first time or recurrent DVT (lower or upper extremity), PE alone or overlapping DVT and PE confirmed by appropriate diagnostic methods (patients must be assessed for eligibility within 30 days of diagnosis)
- •Patients included with recurrent VTE must have completed treatment for the previous VTE episode
排除标准
- •Patients for whom long-term follow-up is not envisaged within the enrolling hospital or the associated primary care physician
- •Patients participating in an interventional study that dictates treatments, visit frequency, or diagnostic procedures
- •Patients with only superficial vein thrombosis (SVT)
结局指标
主要结局
Hospitalization
时间窗: 36 months
Measured by number of occurrences.
Anticoagulation therapy persistence
时间窗: 36 months
Estimation of Anticoagulation therapy will be compared to actual total time Anticoagulation therapy was used by patients.
All cause of mortality
时间窗: 36 months
Causes of death: PE, stroke, cardiac, cancer-related, other...
IVC filter placement
时间窗: 36 months
Measured by number of occurrences.
International Normalized Ratio (INR) Values in Patients treated with Vitamin K Antagonists
时间窗: 36 months
Will be assessed by frequency of INR monitoring, and number of INR readings taken before patient achieved optimum range.
Rate of recurrent symptomatic VTE (DVT and fatal or non-fatal PE)
时间窗: 36 months
Rate of recurrent symptomatic VTE (DVT and fatal or non-fatal PE)
Post Thrombotic Syndrome
时间窗: 36 months
Measured by number of occurrences and severity.
Chronic thromboembolic pulmonary hypertension
时间窗: 36 months
Measured by number of occurrences and severity.
Other urgent interventions for VTE
时间窗: 36 months
Measured by number of occurrences.
Bleeding events
时间窗: 36 months
Frequency, location, severity (classified as major or non-major)
次要结局
- Unstable angina(36 months)
- Stroke(36 months)
- Trans Ischemic Attack (TIA)(36 months)
- Myocardial Infarction(36 months)
- Quality of life and patient treatment satisfaction over a three year period(36 months)