Stroke/Systemic Embolism and Major Bleeding in Patients Newly Treated With Oral Anticoagulants: a Real World Study From Portuguese Administrative Claims Data
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- stroke/systemic embolism event
研究概览
简要总结
To determine if there is any difference in the effectiveness and safety outcomes of patients with NVAF newly treated with apixaban, dabigatran, rivaroxaban and vitamin K antagonists
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Age ≥18 years on the index date.
- •At least 1 OAC (apixaban, dabigatran, rivaroxaban, VKAs) dispensed during the identification period.
排除标准
- •Specialty of the physician responsible for the OAC prescription in the index date is one of the following: orthopedics, general surgery, vascular surgery or any other surgical specialty;
- •Duration of OAC therapy during follow-up inferior to the cut-off defined during the feasibility assessment (except if the patient was admitted to in-hospital care during follow-up);
- •The OAC dispensed in the index date was one of the following: dabigatran 75 mg or rivaroxaban 10 mg
- •Hospital claims lacking a diagnosis code indicative of AF during the study period;
- •Hospital claim indicating a diagnosis or procedure code indicative of pregnancy or childbirth during the study period;
- •Hospital claim indicating a diagnosis or procedure code indicative of valvular heart disease, venous thromboembolism, cardiac surgery, pericarditis, hyperthyroidism and thyrotoxicity during the baseline period;
- •Hospital claim indicating a diagnosis or procedure code indicative of hip and knee replacement surgery during the 6 weeks prior to the index date. Patients with past use of OAC will be excluded. Therefore, patients meeting any of the following criteria will be excluded:
- •Had any OAC (apixaban, dabigatran, edoxaban, rivaroxaban, VKAs) dispensed during the 12-month baseline period;
- •Had >1 OAC dispensed on the index date.
研究组 & 干预措施
Non-Valvular Atrial Fibrillation (NVAF) Adults
Adult patients with NVAF newly treated with apixaban, dabigatran, rivaroxaban or VKAs between June 16, 2014 and December 31, 2018.
干预措施: Apixaban (Drug)
Non-Valvular Atrial Fibrillation (NVAF) Adults
Adult patients with NVAF newly treated with apixaban, dabigatran, rivaroxaban or VKAs between June 16, 2014 and December 31, 2018.
干预措施: dabigatran (Drug)
Non-Valvular Atrial Fibrillation (NVAF) Adults
Adult patients with NVAF newly treated with apixaban, dabigatran, rivaroxaban or VKAs between June 16, 2014 and December 31, 2018.
干预措施: rivaroxaban (Drug)
Non-Valvular Atrial Fibrillation (NVAF) Adults
Adult patients with NVAF newly treated with apixaban, dabigatran, rivaroxaban or VKAs between June 16, 2014 and December 31, 2018.
干预措施: VKAs (Drug)
结局指标
主要结局
stroke/systemic embolism event
时间窗: between 2014 and 2018
To compare the risk of stroke (either ischemic or hemorrhagic) or SE among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.
major bleeding event
时间窗: between 2014 and 2018
To compare the risk of major bleeding (gastrointestinal \[GI\], intracranial \[IC\] and other) among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versusVKAs.
次要结局
- systemic embolism event(2014-2018)
- other major bleeding event(2014-2018)
- major GI bleeding event(2014-2018)
- ischemic stroke event(between 2014 and 2018)
- hemorrhagic stroke event(between 2014 and 2018)
- major IC bleeding event(2014-2018)