A Pharmacoepidemiological Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Practice in Sweden
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 99,999
- 试验地点
- 1
- 主要终点
- Descriptive analysis of demographic and clinical characteristics of patients who are prescribed oral rivaroxaban for the first time in comparison with those who are prescribed standard of care for the first time
研究概览
简要总结
This prospective cohort study will provide information about:
Characteristics of Rivaroxaban use in patients who are prescribed Rivaroxaban for the first time compared to patients who are prescribed standard of care for the first time.
The occurrence of intracranial haemorrhage, gastrointestinal and urogenital bleeding, and the occurrence of non-infective liver disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All male and female patients who have filled a prescription for rivaroxaban, warfarin, aspirin, clopidogrel, ticlopidine, prasugrel and ticagrelor in any pharmacy in Sweden, between December 9, 2011 and December 31, 2018
排除标准
- •For the AF and DVT/PE treatment indications, patients who have filled a prescription for warfarin or another oral anticoagulant at any time between July 1, 2005 and December 9, 2011 will be excluded
研究组 & 干预措施
Rivaroxaban / Cohort 1
Patients who have filled a prescription for rivaroxaban in any pharmacy in Sweden during the study period.
干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)
Standard of care drugs / Cohort 2
Patients who have filled a prescription for standard of care drugs (warfarin, aspirin, clopidogrel, ticlopidine, prasugrel or ticagrelor) in any pharmacy in Sweden during the study period.
干预措施: Standard of care drugs (Drug)
结局指标
主要结局
Descriptive analysis of demographic and clinical characteristics of patients who are prescribed oral rivaroxaban for the first time in comparison with those who are prescribed standard of care for the first time
时间窗: up to 4 years
The following data will be collected and assessed at 2 and 4 years after rivaroxaban market authorization: • age and sex distribution at index date • dose of rivaroxaban at index date • diagnosis associated with the prescribing of the index drug • use of specific prescribed medications confirming ACS indication • use of other prescribed medications • comorbidity based on diagnoses • renal impairment • healthcare utilization (e.g. outpatient visits and hospital admissions)
Safety and effectiveness: occurrence of hospitalization for a) intracranial haemorrhage, (b) gastrointestinal bleeding, (c) urogenital bleeding among users of rivaroxaban in comparison with individuals receiving current standard of care
时间窗: up to 5 years
The two cohorts will be followed up from the index date until 12 months after the end of the enrolment period for potential outcomes For descriptive purposes, annualized crude incidence rates of the major bleeding events will be calculated, accompanied by 95% confidence intervals. For evaluation of safety and effectiveness outcome events, Cox proportional hazards regression model will be used. Propensity score matching will be done to account for confounding by indication.
次要结局
- Occurrence of hospitalization for bleeding events not specified as primary safety outcomes ("other bleeding", secondary safety outcome) in individuals receiving rivaroxaban, in comparison with those receiving current standard of care.(at 5 years)
- Occurrence of non-infective liver disease (secondary safety outcome) in individuals receiving rivaroxaban in comparison with those receiving current standard of care.(at 5 years)
- Outcomes related to effectiveness (DVT/PE, ischaemic stroke or myocardial infarction) in individuals receiving rivaroxaban in comparison with those receiving current standard of care.(at 5 years)
- All-cause mortality as well as cause-specific mortality.(at 5 years)