Real-world Evidence for Non-valvular Atrial Fibrillation Patients Treated With Oral Anticoagulation in the Nordics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 134,897
- 试验地点
- 1
- 主要终点
- Number of participants with ischemic stroke (IS) or systemic embolism (SE)
研究概览
简要总结
Oral anticoagulant (OAC) treatment with either vitamin K antagonists (VKAs) or non-vitamin K antagonist oral anticoagulants (NOACs) is essential in patients with atrial fibrillation for the prevention of stroke or systemic embolism (SE) a condition that happens when a blood clot forms elsewhere in the body and travels through the blood stream to plug another vessel. While there are significant number of real-world publications on the use and outcomes of NOACs for stroke prevention, evidence from routine clinical practice on the use and outcomes of reduced doses of NOACs is scarce. By evaluating routine clinical practice data from national registers in Denmark, Finland, Norway and Sweden, researchers want to gather information about the safety and how well reduced doses of NOACs work in patients with irregularly heartbeats which are not caused by a heart valve problem (non-valvular atrial fibrillation, NVAF). As a primary aim of this study, treatment with low doses of NOACs (Xarelto [generic name rivaroxaban], Eliquis [generic name apixaban] or Pradaxa [generic name dabigatran]) will be compared with VKAs (warfarin) in Nordic patients with NVAF to assess the occurrence of stroke and systemic embolism [effectiveness]) and intracranial hemorrhage a type of bleeding that occurs inside the skull [safety]).
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
- 否
入选标准
- •Patients with a qualifying oral OAC dispensed during the study period
- •A primary diagnosis indicative of atrial fibrillation during the baseline period
排除标准
- •Age < 18 years at index date
- •Died on index date
- •A diagnosis of valvular disease, pregnancy, transient cause of atrial fibrillation or venous thromboembolism in the baseline period or on the index date
- •Hip or knee replacement surgery in the 60 days prior to or on the index date
- •A dispensed prescription of heparin or fondaparinux in the 60 days prior to or on the index date
- •A diagnosis of end-stage kidney disease or renal replacement therapy in the baseline period or on the index date
- •More than one dispensed OAC (any dose of rivaroxaban, apixaban, dabigatran, edoxaban, or warfarin) on the index date
- •A dispensed prescription of an OAC (any dose of rivaroxaban, apixaban, dabigatran, edoxaban, or warfarin) during the baseline period
研究组 & 干预措施
Vitamin K antagonists (VKA)
Participants with NVAF initiating treatment with vitamin K antagonists (VKA)
干预措施: Warfarin (Drug)
Reduced dose NOAC
Participants with NVAF initiating treatment with reduced doses of individual non-vitamin K antagonist oral anticoagulants (NOACs)
干预措施: Rivaroxaban (Xarelto) (Drug)
Reduced dose NOAC
Participants with NVAF initiating treatment with reduced doses of individual non-vitamin K antagonist oral anticoagulants (NOACs)
干预措施: Apixaban (Drug)
Reduced dose NOAC
Participants with NVAF initiating treatment with reduced doses of individual non-vitamin K antagonist oral anticoagulants (NOACs)
干预措施: Dabigatran (Drug)
结局指标
主要结局
Number of participants with ischemic stroke (IS) or systemic embolism (SE)
时间窗: Retrospective analysis from 2010 - 2018
Evaluation will be done in participants treated with reduced doses of individual NOACs and with VKA
Number of participants with intracranial haemorrhage (ICH)
时间窗: Retrospective analysis from 2010 - 2018
Evaluation will be done in participants treated with reduced doses of individual NOACs and with VKA
次要结局
未报告次要终点