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临床试验/NCT02769078
NCT02769078已完成不适用

Replication Of An Early Evaluation Of 30-Day Readmissions Among Nonvalvular Atrial Fibrillation Patients Treated With Dabigatran, Rivaroxaban, Apixaban, or Warfarin In The U.S

Bristol-Myers Squibb0 个研究点目标入组 14,201 人开始时间: 2014年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
14,201
主要终点
Proportion of NVAF patients with bleeding-related hospital readmissions from inpatient hospitalization records collected from the Cerner Health Facts hospital database

研究概览

简要总结

The overall objective of this proposal is to execute a real-world database analysis to evaluate hospital readmissions among hospitalized nonvalvular atrial fibrillation (NVAF) patients in the U.S.

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

  • Have a primary or secondary diagnosis of AF identified by International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes from the Cerner Health Facts hospital database between January 1, 2012 and August 31, 2014
  • Age 18 years or older as of initial hospitalization with AF diagnosis

排除标准

  • Have any primary or secondary diagnosis code or procedure code for valvular disease during the study period. This exclusion criterion is consistent with that used in other previous BMS Health Economics and Outcomes Research (HEOR) studies and is used to ensure that the study populations are NVAF patients
  • Received multiple types of NOACs during the index hospitalization. Preliminary analysis showed that very few patients receive multiple types of NOACs during the same hospitalization. This exclusion criterion will allow to cleanly group patients into the different New oral anticoagulant (NOAC) usage groups

研究组 & 干预措施

Patients who received dabigatran

Patients who received dabigatran

干预措施: dabigatran (Drug)

Patients who received rivaroxaban

Patients who received rivaroxaban

干预措施: rivaroxaban (Drug)

Patients who received apixaban

Patients who received apixaban

干预措施: apixaban (Drug)

Patients who received warfarin

Patients who received warfarin

干预措施: warfarin (Drug)

结局指标

主要结局

Proportion of NVAF patients with bleeding-related hospital readmissions from inpatient hospitalization records collected from the Cerner Health Facts hospital database

时间窗: January 1, 2012 to August 31, 2014

Proportion of NVAF patients with bleeding-related hospital readmissions that occur within 30 days of the hospitalization of NVAF patients treated with dabigatran, rivaroxaban, apixaban, or warfarin in the inpatient setting.

次要结局

  • Cost associated with bleeding-related hospital readmissions from inpatient hospitalization records collected from the Cerner Health Facts hospital database(January 1, 2012 to August 31, 2014)
  • Proportion of NVAF patients with all cause hospital readmissions and the associated costs from inpatient hospitalization records collected from the Cerner Health Facts hospital database(January 1, 2012 to August 31, 2014)

研究者

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

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