Real-world Comparative Effectiveness of Rivaroxaban Versus Low-molecular-weight Heparin (LMWH) and Phenprocoumon for the Treatment and Secondary Prevention of Venous Thromboembolism (RECENT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 22,153
- 试验地点
- 1
- 主要终点
- Risk of recurrent venous thromboembolic (VTE) events in VTE patients treated with rivaroxaban compared to patients treated with LMWH and Phenprocoumon
研究概览
简要总结
Researcher in this study want to compare the effectiveness of Rivaroxaban (Xarelto) versus low-molecular-weight heparin (LMWH) and phenprocoumon for the treatment and secondary prevention of venous thromboembolism by evaluating routine clinical practice data from research database in Germany. VTE is defined by a blood clot in the leg or lower extremity (deep vein thrombosis) or a blood clot in the lung (pulmonary embolism). Treatment of VTE traditionally consists of acute anticoagulation treatment with heparin (mainly LMWH), followed by maintenance oral anticoagulation with vitamin-K antagonists (in Germany mainly phenprocoumon). Rivaroxaban, a direct-acting oral anticoagulants (DOAC), is an alternative VTE treatment and has been approved for both the acute and maintenance phase of VTE treatment. The study will enroll adult male or female patients who are newly diagnosed with VTE and are already on the treatment with Rivaroxaban or LMWH and phenprocoumon. Researchers are especially interested whether patients experience under treatment any VTE events or fatal bleedings.
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
- •At least one new diagnosis of VTE during the inclusion period:
- •Ambulatory diagnosis, coded as verified,
- •Primary hospital discharge diagnosis.
- •Secondary hospital discharge diagnosis The quarter of the first VTE diagnosis in the inclusion period will be defined as the index quarter. For hospital diagnoses, the date of admission will be used to define the index quarter.
- •The 12 months prior to the index date will define the baseline period for all included patients. Patients treated with anticoagulation regimens other than defined above (e.g. other DOACs) will not be included in the study. All patients will have to fulfill the additional inclusion criteria:
- •Continuous enrolment in the baseline period
- •≥ 18 years of age at index date
排除标准
- •A verified ambulatory or primary/ secondary hospital discharge diagnosis of VTE in the baseline period;
- •A verified ambulatory or primary/ secondary hospital discharge diagnosis of atrial fibrillation in the baseline period; Individuals with documented cardiac valve surgery in the baseline period;
- •A verified ambulatory or primary/ secondary hospital discharge diagnosis indicating pregnancy in the baseline period;
- •A prescription of any anticoagulation treatment (heparins; vitamin-K antagonists; rivaroxaban; other DOACs) in the baseline period;
- •A verified ambulatory or primary/ secondary hospital discharge diagnosis of end-stage kidney disease or a claim for dialysis in the baseline period;
- •A prescription of contraindicated drug for rivaroxaban due to drug interactions (i.e. azole antifungals and HIV protease inhibitors) in the 60 days before or on the index date.
- •Patients assigned to rivaroxaban exposure groups who were initially treated with a dose strength other than 15 mg or 20 mg per tablet.
研究组 & 干预措施
Rivaroxaban
The source population of this study will include all insured members of more than 60 German statutory health insurances (SHIs) contributing data to the InGef database.
干预措施: Rivaroxaban (Xarelto, BAY 59-7939) (Drug)
Low-molecular-weight heparin (LMWH) and Phenprocoumon
The source population of this study will include all insured members of more than 60 German statutory health insurances (SHIs) contributing data to the InGef database.
干预措施: LMWH and Phenprocoumon (Drug)
结局指标
主要结局
Risk of recurrent venous thromboembolic (VTE) events in VTE patients treated with rivaroxaban compared to patients treated with LMWH and Phenprocoumon
时间窗: Retrospective data from January 2013 to December 2018
A recurrent VTE event will be defined as a hospitalization with a primary hospital discharge diagnoses for VTE for which the admission date was \>14 days after the index date. Non-interventional retrospective cohort study based on German claims data from the InGef (Institute for Applied Healthcare Research Berlin) research database between January 2013 and December 2018.
次要结局
- Risk of fatal bleeding in VTE patients treated with rivaroxaban compared to patients treated with LMWH and Phenprocoumon(Retrospective data from January 2013 to December 2018)