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临床试验/NCT02661568
NCT02661568已完成不适用

Anticoagulation Treatment Patterns and Persistence After Acute Venous Thromboembolism in the UK in Routine Clinical Practice: A Retrospective Database Study of the Clinical Practice Research Datalink and the Hospital Episode Statistics Dataset

Bristol-Myers Squibb0 个研究点目标入组 38,409 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
38,409
主要终点
Anticoagulation treatment patterns for patients following acute Venous Thromboembolism (VTE) based on all VTE events that occur during the study period

研究概览

简要总结

This study will utilize a retrospective cohort design. Using the Clinical Practice Research Datalink (CPRD) linked with Hospital Episode Statistics (HES) datasets, all patients with a record of VTE diagnosis between 1 April, 2008 and 31 March, 2013 will be identified and followed from the occurrence of VTE (index date) to the first of 24 months after the index date, end of the study period, leaving the database, or death.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • VTE events will be included if:
  • they are identified by at least one Read code diagnosis of acute VTE in the CPRD, or one ICD-10 code of VTE in the HES database, during the study period; and
  • they occurred in patients ≥ 18 years old at time of VTE occurrence; and
  • CPRD acceptability quality criteria are present

排除标准

  • VTE events will be excluded if:
  • Patients have fewer than 12 months of computerized data available prior to VTE occurrence. The date of start of computerized records will be the latter of the patient's date of current registration with the practice or the practice's Up-to-Standard (UTS) date (date from which practice data is of research quality)

结局指标

主要结局

Anticoagulation treatment patterns for patients following acute Venous Thromboembolism (VTE) based on all VTE events that occur during the study period

时间窗: up to 24 months following VTE occurrence

Anticoagulation treatment pattern includes type of anticoagulant (AC), duration of AC treatment, switching between ACs and switching from AC to aspirin or other antiplatelet agents (APA).

次要结局

  • Demographic characteristics (age, gender) of patients with acute VTE(up to 24 months following VTE occurrence)
  • Clinical characteristics (comorbidities, concomitant treatments, medical and surgical history) of patients with acute VTE(up to 24 months following VTE occurrence)
  • Rates of unplanned (emergency) hospital admission, major surgery, major bleeding, and VTE recurrence(up to 24 months following VTE occurrence)
  • Baseline demographic and clinical characteristics associated with the duration of AC treatment after VTE(up to 24 months following VTE occurrence)
  • Baseline demographic and clinical characteristics associated with novel oral anticoagulant (NOAC) treatment compared with vitamin K antagonist (VKA) treatment following VTE(up to 24 months following VTE occurrence)

研究者

发起方
Bristol-Myers Squibb
申办方类型
Industry
责任方
Sponsor

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