Xarelto + Acetylsalicylic Acid: Treatment Patterns and Outcomes in Patients With Atherosclerosis. A Non-interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 5,798
- 试验地点
- 1
- 主要终点
- Descriptive analysis of prior antithrombotic treatment
研究概览
简要总结
In this study researchers want to gain more information on treatment patterns of patients treated with Xarelto in combination with acetylsalicylic acid (ASA). Both drugs reduce the risk of blood clots via different pathways. The study will enroll adult patients suffering from coronary artery disease (narrowing or blockage of vessels that supply the heart with blood) or peripheral artery disease (narrowing or blockage of vessels that supply the legs or head with blood). The study will focus on information on when and why physicians are starting to treat patients with Xarelto in addition to ASA, treatment duration, reasons to discontinue treatment and previous therapies. The study will also look into treatment outcomes for patients being treated with a combination of Xarelto and ASA by their physicians.
详细描述
The study aims to collect real-world data on treatment patterns and decision points for treatment in patients with coronary artery disease (CAD) and/ or peripheral artery disease (PAD) treated with rivaroxaban 2.5 mg [twice daily] for the prevention of major cardiovascular events in adult patients with CAD at high risk of ischemic events and/ or documented PAD and to describe outcomes of an antithrombotic regime based on dual pathway inhibition (vascular dose of rivaroxaban 2.5 mg [twice daily] plus low-dose ASA [once daily]) across the broad range of patient risk profiles encountered in routine clinical practice.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with diagnosis Coronary Artery Disease (CAD) or Peripheral Artery Disease (PAD).
- •Treatment according to local marketing authorization, rivaroxaban 2.5 mg twice daily started within 4 weeks prior to enrolment. Only in those countries with a marketing authorization of rivaroxaban in the acute coronary syndrome (ACS) indication, also patients already on rivaroxaban treatment for ACS, who are subsequently fulfilling criteria for CAD, are allowed to be enrolled within 4 weeks of this decision being made.
排除标准
- •Patients who will be treated with chronic anticoagulation therapy other than rivaroxaban 2.5 mg given for CAD/PAD.
- •Participation in an interventional trial.
研究组 & 干预措施
CAD/PAD-patients
Adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) from Europe, Asia, Latin America and Canada, who are treated with a combination of rivaroxaban and acetylsalicylic acid to prevent atherothrombotic events
干预措施: Rivaroxaban (BAY59-7939, Xarelto) (Drug)
CAD/PAD-patients
Adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) from Europe, Asia, Latin America and Canada, who are treated with a combination of rivaroxaban and acetylsalicylic acid to prevent atherothrombotic events
干预措施: Acetylsalicylic acid (Drug)
结局指标
主要结局
Descriptive analysis of prior antithrombotic treatment
时间窗: At baseline
Descriptive analysis of patient history of CAD
时间窗: At baseline
Descriptive analysis of concomitant secondary prevention therapies
时间窗: Up to 30.5 months
Decision point for start of rivaroxaban
时间窗: At baseline
Time point of start of medication in relation to disease progress and/ or occurrence of ischemic events.
Planned duration of treatment with acetylsalicylic acid
时间窗: At baseline
Descriptive analysis of patient history of PAD
时间窗: At baseline
Descriptive analysis of concomitant antithrombotic treatment
时间窗: Up to 30.5 months
Descriptive analysis of prior secondary prevention therapies
时间窗: At baseline
Reason for start of rivaroxaban
时间窗: At baseline
Reasons include past ischemic events, co-morbidities and medical history.
Reason for discontinuation of rivaroxaban
时间窗: Up to 30.5 months
Planned duration of treatment with rivaroxaban
时间窗: At baseline
Actual duration of treatment with rivaroxaban
时间窗: Up to 30.5 months
Actual duration of treatment with acetylsalicylic acid
时间窗: Up to 30.5 months
次要结局
- Total walking distance of PAD patients(Up to 30.5 months)
- Pain-free walking distance of PAD patients(Up to 30.5 months)
- Occurrence of major adverse cardiac events(Up to 30.5 months)
- Occurrence of stroke(Up to 30.5 months)
- Occurrence of myocardial infarction(Up to 30.5 months)
- Occurrence of cardiovascular death(Up to 30.5 months)
- Occurrence of chronic limb ischemia(Up to 30.5 months)
- Occurrence of death from cardiovascular events(Up to 30.5 months)
- Occurrence of death from any cause(Up to 30.5 months)
- Occurrence of cardiac revascularization procedures(Up to 30.5 months)
- Occurrence of peripheral revascularization procedures(Up to 30.5 months)
- Occurrence of carotid revascularization procedures(Up to 30.5 months)
- Occurrence of acute/severe limb ischemia(Up to 30.5 months)
- Occurrence of major adverse limb events(Up to 30.5 months)
- Occurrence of major amputation(Up to 30.5 months)
- Anti-thrombotic treatment pattern after major adverse limb event(Up to 30.5 months)
- Occurrence of thromboembolic events(Up to 30.5 months)
- Occurrence of haemorrhagic events(Up to 30.5 months)
- Occurrence of hospitalizations(Up to 30.5 months)
- Duration of hospitalization(Up to 30.5 months)