Xarelto + Acetylsalicylic Acid: Treatment Patterns and Outcomes Across the Disease Continuum in Patients With CAD and/or PAD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 3,189
- 试验地点
- 1
- 主要终点
- Descriptive analysis of prior secondary prevention therapies
研究概览
简要总结
The study will focus on effectiveness and safety of rivaroxaban (Xarelto) when given together with acetylsalicylic acid (combination therapy) to patients suffering from coronary artery disease (a condition that affects the blood vessels supplying the heart) and / or peripheral artery disease (a condition that affects the blood vessels of the lower limbs) in the routine clinical practice. The study will help to collect data for prevention cardiovascular death, myocardial infarction (MI), stroke and major adverse limb events in adult patients. The study will focus on information on when and why physicians are starting to treat patients with combination therapy, treatment duration, reasons to discontinue treatment and previous therapies. The study will also investigate treatment outcomes for patients being treated with a combination therapy by their physicians.
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
- •Adult (≥18 years) patient (except Taiwan ≥ 20 years old).
- •Diagnosis of CAD or symptomatic PAD.
- •Treatment according to local marketing authorization, rivaroxaban 2.5 mg [BID] plus Acetylsalicylic acid (ASA) 75-100 mg [OD] started up to 4 weeks before or after the ICF is signed.
- •Only in those countries with a marketing authorization of rivaroxaban in the Acute Coronary Syndrome (ACS) indication, patients already on rivaroxaban treatment for ACS for more than 4 weeks, who are subsequently fulfilling criteria for CAD, are also allowed to be enrolled.
排除标准
- •Contra-indications according to the local marketing authorization.
- •Patients who will be treated with chronic anticoagulation therapy other than rivaroxaban 2.5 mg given for CAD/PAD.
- •Participation in an interventional trial.
- •Enrolment in the XATOA study.
研究组 & 干预措施
CAD/PAD-patients
Adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) who are treated with a combination of rivaroxaban and acetylsalicylic acid.
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) who are treated with a combination of rivaroxaban and acetylsalicylic acid.
干预措施: Acetylsalicylic acid (Drug)
结局指标
主要结局
Descriptive analysis of prior secondary prevention therapies
时间窗: At baseline
Health status by questionnaire EQ-5D-5L
时间窗: Up to 34 months
Self-reported health-related quality of life is measured with EQ-5D at the initial visit and at each follow-up visit. Items are scored from 1 (no problems) to 5 (extreme problems) leading to a total score from 0 (worst imaginable health) to 100 (best imaginable health).
Descriptive analysis of clinical characteristics of CAD participants
时间窗: At baseline
Actual duration of treatment with ASA
时间窗: Up to 34 months
Descriptive analysis of clinical characteristics of PAD participants
时间窗: At baseline
Descriptive analysis of prior antithrombotic treatment
时间窗: At baseline
Descriptive analysis of concomitant antithrombotic treatment
时间窗: Upto 34 months
Descriptive analysis of concomitant secondary prevention therapies
时间窗: Up to 34 months
Decision point to start rivaroxaban
时间窗: At baseline
Time point of start of medication in relation to disease progress and/ or occurrence of ischemic events
Reasons for discontinuation of rivaroxaban
时间窗: Up to 34 months
Reason to start rivaroxaban
时间窗: At baseline
Reasons include past ischemic events, co-morbidities and medical history.
Planned duration of treatment with rivaroxaban
时间窗: At baseline
Actual duration of treatment with rivaroxaban
时间窗: Up to 34 months
Planned duration of treatment with Acetylsalicylic acid (ASA)
时间窗: At baseline
次要结局
- Total walking distance per individual for PAD participants(Up to 34 months)
- Pain free walking distance per individual for PAD participants(Up to 34 months)
- Number of participants with peripheral revascularization procedures(Up to 34 months)
- Number of deaths due to cardiovascular events(Up to 34 months)
- Number of deaths due to any cause(Up to 34 months)
- Number of participants with major adverse cardiovascular events (MACE)(Up to 34 months)
- Number of participants with carotid revascularization procedures(Up to 34 months)
- Number of participants with lower limb revascularization procedures.(Up to 34 months)
- Number of participants with major adverse limb events (MALE)(Up to 34 months)
- Number of participants with cardiac revascularization procedures(Up to 34 months)
- Number of participants with antithrombotic treatment after MALE(Up to 34 months)
- Number of hospitalizations(Up to 34 months)
- Number of participants with MACE or MALE(Up to 34 months)
- Number of participants with thromboembolic events(Up to 34 months)
- Number of participants with haemorrhagic events and complications(Up to 34 months)
- Duration of hospitalizations(Up to 34 months)
- Patient-reported walking impairment by Walking Impairment Questionnaire (WIQ) for PAD participants(Up to 34 months)