Observational Studies in Cancer Associated Thrombosis for Rivaroxaban - United States Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 3,708
- 试验地点
- 1
- 主要终点
- All-cause mortality
研究概览
简要总结
Patients with active cancer are ~5-fold more likely to develop a venous thromboembolism (VTE) than those without. When VTE occurs, cancer patients carry an up to a 3-fold higher rate of thrombosis recurrence and ~twice the risk of bleeding during anticoagulation. Therefore, it is critical to utilize anticoagulants that optimize efficacy while minimizing bleeding risk when treating cancer-associated thrombosis (CAT).
Guidelines list direct-acting oral anticoagulants (DOACs) as an alternative to low molecular-weight heparin (LMWH) for treatment of CAT. The strength-of-recommendation for DOACs is based on data from multiple randomized controlled trials (RCTs) comparing them to LMWHs to treat CAT, with results suggesting DOACs may reduce thrombosis risk but with potentially more frequent bleeding (particularly in those with certain gastrointestinal and genitourinary cancers).
Observational studies evaluating DOACs for CAT treatment have been published, but these studies have been either single-arm, evaluated cancer subtypes not recommended for DOAC treatment, were of limited sample size and/or employed heterogeneous definitions of active cancer. We seek to evaluate the effectiveness and safety of rivaroxaban versus LMWH for CAT treatment in active cancer patients using a large de-identified electronic health record database.
Retrospective cohort analysis using US Optum® De-Identified EHR data. We will use Optum EHR (electronic health records) data from November January 1, 2012 through latest available data (currently September 2020).
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
- •Be ≥18 years of age at the time of anticoagulation initiation.
- •Have active cancer admitted to the hospital, emergency department or observation unit for acute DVT and/or PE.
- •Treated with rivaroxaban (or any DOAC in secondary analysis) or LMWH as their first anticoagulant on day 7 post-acute CAT event diagnosis (index date) o increase the probability of accurately classifying patients' intended outpatient anticoagulant for CAT treatment and that patients are compared at the same point from diagnosis.
- •Have been active in the data set for at least 12-months prior to the index event (based on the "First Month Active" field) and had at least one provider visit in the 12-months prior to the acute VTE event (baseline period).
排除标准
- •Evidence of atrial fibrillation, recent hip/knee replacement (within 35 days of index VTE), ongoing VTE treatment, valvular heart disease defined as any rheumatic heart disease, mitral stenosis, or mitral valve repair/replacement.
- •Pregnancy.
- •Initiation of rivaroxaban at a dose other than 15 mg twice daily or non-therapeutic doses of other DOAC or LMWH (e.g., enoxaparin at a dose other than 1 mg/kg twice daily or 1.5 mg/kg once daily; dalteparin at a dose other than 200 IU/kg of total body weight)
- •Evidence of use of anticoagulation use during the 12-months prior per written prescription or patient self-report
研究组 & 干预措施
Cancer patients with acute venous thromboembolism (VTE)
Cancer-associated thrombosis (CAT) patients treated with Rivaroxaban or any DOAC (Direct Oral Anticoagulants) or LMWH (Low molecular weight heparin).
干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)
Cancer patients with acute venous thromboembolism (VTE)
Cancer-associated thrombosis (CAT) patients treated with Rivaroxaban or any DOAC (Direct Oral Anticoagulants) or LMWH (Low molecular weight heparin).
干预措施: Low molecular weight heparin (LMWH) (Drug)
Cancer patients with acute venous thromboembolism (VTE)
Cancer-associated thrombosis (CAT) patients treated with Rivaroxaban or any DOAC (Direct Oral Anticoagulants) or LMWH (Low molecular weight heparin).
干预措施: Direct Oral Anticoagulants (DOAC) (Drug)
结局指标
主要结局
All-cause mortality
时间窗: at 3 month after treatment
Risk of recurrent VTE
时间窗: at 3 month after treatment
Any clinically-relevant bleeding-related hospitalization
时间窗: at 3 month after treatment
Cunningham algorithm for identification of bleeding-associated hospitalizations
次要结局
- All-cause mortality at 6- and 12-months.(at 6 and 12 months)
- Critical organ bleeding(at 3, 6 and 12 months)
- Recurrent VTE at 6- and 12-months post-index VTE(at 6 and 12 months post-index VTE)
- Duration of anticoagulation treatment(at 3, 6 and 12 months)
- Any clinically-relevant bleeding-related hospitalization(at 6 and 12 months)
- Composite of any major or clinically-relevant nonmajor bleeding-related hospitalization at 6- and 12-months post-index VTE(at 6 and 12 months post-index VTE)
- Intracranial hemorrhage (ICH)(at 3, 6 and 12 months)
- Extracranial bleeding-related hospitalizations(at 3, 6 and 12 months)
- Incidence rates any clinically-relevant bleeding-related to recurrent VTE(at 3, 6 and 12 months)
- LMWH discontinuation rates at 3-, 6- and 12-months follow-up(at 3, 6 and 12 months)
- Incidence rates of recurrent VTE(at 3, 6 and 12 months)
- All cause-mortality(at 3, 6 and 12 months)
- DOAC discontinuation rates at 3-, 6- and 12-months follow-up(at 3, 6 and 12 months)