Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in Daily Clinical Practice - A French Cohort Within the Nationwide Claims and Hospital Database
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
- Major Bleeding
研究概览
简要总结
The purpose of the study is to compare the one-year and two-year risk of each of the following individual outcomes: Stroke and systemic embolism (SE), major bleeding and death between new users of anticoagulant for Stroke prevention in atrial fibrillation (SPAF) during drug exposure: rivaroxaban versus Vitamin K antagonists (VKA), and rivaroxaban versus dabigatran
详细描述
Main objective: To compare the one-year and two-year risk of each of the following individual outcomes: Stroke and systemic embolism (SE), major bleeding and death between new users of anticoagulant for SPAF during drug exposure: rivaroxaban versus VKA, and rivaroxaban versus dabigatran.
Secondary objectives:
- To describe the drug exposure to rivaroxaban, dabigatran, and VKA for SPAF in new users, as well as and pattern of use;
- To compare the one-year and two-year risk of the following individual outcomes: a composite of stroke and SE, major bleeding and death, clinically relevant bleeding (CRB) and acute coronary syndrome (ACS) between new users of anticoagulant for SPAF during drug exposure: rivaroxaban versus VKA, and rivaroxaban versus dabigatran;
- To estimate the cumulative incidence and the incidence rate of each individual main and secondary outcome (stroke and SE, major bleeding, CRB, death, composite criteria, and ACS), as well as according to individual diagnose of each of these outcomes, during drug exposure for rivaroxaban, dabigatran, and VKA;
- To estimate the cumulative incidence of each individual main and secondary outcome (stroke and SE, major bleeding, CRB, death, composite criteria, and ACS), as well as according individual diagnose of each of these outcomes during post-anticoagulant exposure for rivaroxaban, dabigatran, and VKA (i.e. after anticoagulant discontinuation);
- To assess outcome risk factors, including (but not limited to), gender, age, stroke and bleeding risk scores (CHA2DS2-VASc and HAS-BLED), low or high dosage at index date for DOAC, drug predisposing to bleeding during drug exposure and significant baseline characteristics;
- To describe and compare healthcare resources utilisation related to SPAF during rivaroxaban, dabigatran, and VKA exposure, including outcomes, and their related costs from the societal perspective and from the French healthcare insurance perspective.
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
- 2 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Definite non-valvular atrial fibrillation:
- •A first reimbursed dispensation of rivaroxaban, dabigatran, or VKA in 2013 or 2014, and
- •No previous DOAC (rivaroxaban, dabigatran, apixaban) or VKA dispensation during the previous three years,
- •Definite AF information in the database Probable non-valvular atrial fibrillation:-
- •A first reimbursed dispensation of rivaroxaban, dabigatran, or VKA in 2013 or 2014, and
- •No previous DOAC (rivaroxaban, dabigatran, apixaban) or VKA dispensation during the previous three years,
- •Probable AF information in the database (using the development of an AF disease score, see variables definition below),
排除标准
- •Patients with Rheumatic valve disease
- •Patients with valve replacement
- •Patients treated with anticoagulants for venous
- •thromboemboslim or prevention of venous
- •thromboembolism after orthopedic surgery
研究组 & 干预措施
Group 2
Adult patients with nonvalvular atrial fibrillation (NVAF) treated with vitamin k anatognists
干预措施: Vitamin K antagonists (Drug)
Group 3
Adult patients with nonvalvular atrial fibrillation (NVAF) treated with dabigatran
干预措施: dabigatran (Pradaxa) (Drug)
Group 1
Adult patients with nonvalvular atrial fibrillation (NVAF) treated with rivaroxaban
干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)
结局指标
主要结局
Major Bleeding
时间窗: One year and Two Year
Hospitalization with haemorrhagic stroke, other critical organ or site bleeding (intraspinal, intraocular,retroperitoneal, intraarticular or pericardial, or intramuscular), Other bleeding with a transfusion during hospital stay, or resulting in death. To compare one year and two year risk between new users of anticoagulant for SPAF during drug exposure: rivaroxaban versus VKA, and rivaroxaban versus dabigatran.
Death
时间窗: One year and Two Year
All-cause death. To compare one year and two year risk between new users of anticoagulant for SPAF during drug exposure: rivaroxaban versus VKA, and rivaroxaban versus dabigatran.
Stroke and systemic embolism (Effectiveness outcome)
时间窗: One year and Two Year
Hospitalization with ischemic or undefined stroke or other systemic arterial embolism or surgical procedure for systemic arterial embolism To compare one year and two year risk between new users of anticoagulant for SPAF during drug exposure: rivaroxaban versus VKA, and rivaroxaban versus dabigatran.
次要结局
- A composite of stroke and SE, major bleeding and death, clinically relevant bleeding and acute coronary syndrome(One year and Two Year)
- Pattern of use (Exposure, Adherence, Discontinuation, Switch)(Up to two years)
- Cumulative incidence of Stroke and SE, major bleeding, clinically relevant bleeding, death, composite criteria, and acute coronary syndrome as well as according individual diagnose of each of these outcomes(Up to two years)
- Healthcare resources utilisation(Up to two years)
- Cumulative incidence and incidence rate of stroke and SE, major bleeding, clinically relevant bleeding, death, composite criteria, and acute coronary syndrome as well as according individual diagnose of each of these outcomes(Up to two years)