A Pharmacoepidemiological Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Pratice in the Netherlands.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 208,958
- 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 Acenocoumarol 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
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All male and female patients who have been prescribed for the first time either Rivaroxaban or standard of care from the date of market authorization of rivaroxaban to Dec 31, 2017
排除标准
- •Patients who have any record of being dispensed their index drug in the year before index date (i.e. cohort entry), or who qualify for both cohorts on the same day will be excluded
研究组 & 干预措施
Rivaroxoban
Patients who have been prescribed Rivaroxaban for the first time
干预措施: Rivaroxoban (Xarelto, Bay59-7939) (Drug)
Standard of care
Patients who have been prescribed standard of care for the first time
干预措施: Standard of care (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 8 years
Age and sex distribution at index date Proportion of patients defined as naïve, non-naïve, recent switchers and distant switchers Type and estimated duration of other anticoagulant use among the non-naïve group and for all patients Number of pregnancies and pregnancy outcomes' Use of specific prescribed medications confirming ACS indication Use of other prescribed medications Renal disease based on in- and outpatient diagnoses Hospital admissions for bleeding Healthcare utilization (e.g. number of hospital admissions). Smoking status Body mass index (BMI)
Characteristics of rivaroxaban use in comparison with standard of care
时间窗: up to 8 years
Estimated dose of index drug at index date and estimated duration of treatment Where available, the diagnosis associated with the prescribing of the index drug (where not available, estimated dose and duration of index drug will be used as a proxy for the associated diagnosis among rivaroxaban users) Dispensed amount (can be used to estimate duration of treatment)
Safety: occurrence of intracranial haemorrhage leading to hospitalization among users of rivaroxaban in comparison with individuals receiving current standard of care
时间窗: up to 8 years
Cases of intracranial haemorrhage will be identified in patients admitted to the hospital that meet the criteria for one of the three following categories: Incident cases of intracerebral haemorrhage Incident cases of subarachnoid haemorrhage incident cases of epidural, dural, subdural and arachnoid haemorrhage Potential cases will be identified by hospital discharge diagnoses
Safety: occurrence of gastrointestinal bleeding leading to hospitalization among users of rivaroxaban in comparison with individuals receiving current standard of care
时间窗: up to 8 years
A patient will have to meet the following criteria to be considered a case of gastrointestinal bleeding: The specific site of bleeding originating in the upper or lower gastrointestinal tract or, more specifically, in the oesophagus, stomach, duodenum, jejunum, ileum, colon or rectum. For upper gastrointestinal bleeding, the lesion type being erosion, gastritis, duodenitis or peptic (gastric or duodenal) ulcer. The lesion type being NOT related to cancer. Cases will be identified by hospital discharge diagnoses (ICD-9-CM).
Safety: occurrence urogenital bleeding leading to hospitalization among users of rivaroxaban in comparison with individuals receiving current standard of care
时间窗: up to 8 years
A patient will have to be admitted to the hospital for urogenital bleeding, i.e. the specific site of bleeding originating in the urogenital tract. Cases will be identified by hospital discharge diagnoses (ICD-9-CM).
次要结局
- Safety: occurrence of bleeding events leading to hospitalization not specified as primary safety outcomes ("other bleeding") in individuals receiving rivaroxaban, in comparison with those receiving current standard of care(up to 8 years)
- Safety: occurrence of non-infective liver disease leading to hospitalization in individuals receiving rivaroxaban in comparison with those receiving current standard of care(up to 8 years)
- Effectiveness: occurrence of deep vein thrombosis (DVT) or pulmonary embolism (PE) in individuals receiving rivaroxaban in comparison with those receiving current standard of care(up to 8 years)
- Effectiveness: occurrence of Ischaemic stroke in individuals receiving rivaroxaban in comparison with those receiving current standard of care(up to 8 years)
- All-cause mortality as well as cause-specific mortality(up to 8 years)
- Effectiveness: occurrence acute myocardial infarction (MI) in individuals receiving rivaroxaban in comparison with those receiving current standard of care(up to 8 years)