A Phase IV Study to Investigate the Safety and Effectiveness of Rivaroxaban(Xarelto) 2.5mg [BID]+Acetylsalicylic Acid(ASA) 75mg [OD] in Indian Patients With Coronary and/or Symptomatic Peripheral Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Number of participants with haemorrhagic events and complications
研究概览
简要总结
This is an observational study in which data from Indian people with coronary artery disease and / or symptomatic peripheral artery disease who will be receiving the drug rivaroxaban (Xarelto) are studied.
Coronary artery disease (CAD) is a condition where the arteries that bring blood and oxygen to the heart become hardened and narrow. Peripheral artery disease (PAD) is a condition with reduced blood flow in the arteries of the legs and arms. People with CAD and / or PAD with symptoms may receive rivaroxaban from their doctors to prevent problems (for example, stoke) caused by blood clots and hardening of the arteries.
In this study researcher want to gather more information on the safety and the effectiveness of rivaroxaban when given together with the drug acetylsalicylic acid (also known as "aspirin") to people with CAD and / or PAD with symptoms in the routine practice in India. Researchers are especially interested whether patients under treatment experience any events such as minor or major bleedings, stroke, sickness of the heart or blood vessels. In addition, information on why and when treating doctors decide to start or stop the treatment with rivaroxaban and acetylsalicylic acid is of interest to the researchers.
The study plans to enroll about 300 male or female patients who are at least 18 years old and are already treated with the two drugs or at least with rivaroxaban.
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.
- •Diagnosis of CAD or PAD.
- •Treatment with Rivaroxaban 2.5mg tablet, co administered with acetylsalicylic acid (ASA), for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events within 4 weeks prior to enrolment. 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.
- •Patients who are willing to participate in this study (signed informed consent).
排除标准
- •Contra-indications according to the local marketing authorization.
- •Patients who will be treated with chronic anticoagulation therapy other than rivaroxaban 2.5mg given for CAD/PAD.
- •Participation in an interventional trial.
研究组 & 干预措施
Treatment
Female and male patients with a diagnosis of CAD or symptomatic PAD will be enrolled within 4 weeks after the decision for treatment with rivaroxaban 2.5mg [BID] plus ASA 75mg [OD] has been made by the investigator.
干预措施: Rivaroxaban (Xarelto,Bay 59-7939) (Drug)
Treatment
Female and male patients with a diagnosis of CAD or symptomatic PAD will be enrolled within 4 weeks after the decision for treatment with rivaroxaban 2.5mg [BID] plus ASA 75mg [OD] has been made by the investigator.
干预措施: Acetylsalicylic acid(ASA) (Drug)
结局指标
主要结局
Number of participants with haemorrhagic events and complications
时间窗: Up to 13 months
Consisting of minor and major bleeding events. The major bleeding complications are collected according to the International Society on Thrombosis and Haemostasis (ISTH) criteria as a composite of fatal bleeding, symptomatic bleeding into a critical organ (such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome), bleeding into surgical site requiring reoperation, bleeding leading to hospitalization.
次要结局
- Planned and actual duration of treatment with rivaroxaban 2.5 mg [BID].(Up to 13 months)
- Number of participants with major adverse cardiovascular events (MACE)(Up to 13 months)
- Number of participants with carotid revascularization procedures(Up to 13 months)
- Duration of hospitalizations(Up to 13 months)
- Number of participants with history and diagnosis of CAD or PAD(Up to 13 months)
- Dose of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PAD(Up to 13 months)
- Reasons and decision points for introducing rivaroxaban 2.5 mg [BID](Up to 13 months)
- Number of participants with major adverse limb events (MALE)(Up to 13 months)
- Number of participants with all-cause mortality(Up to 13 months)
- Number of participants with peripheral revascularization procedures(Up to 13 months)
- Type of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PAD(Up to 13 months)
- Reasons for discontinuation of rivaroxaban 2.5 mg [BID].(Up to 13 months)
- Number of participants with revascularization procedures and prior interventions (PCI, CABG), peripheral revascularization procedures(Up to 13 months)
- Planned and actual duration of treatment with ASA 75 mg [OD](Up to 13 months)
- Number of participants with thromboembolic events(Up to 13 months)
- Number of participants with cardiovascular mortality(Up to 13 months)
- Number of participants with cardiac revascularization procedures(Up to 13 months)
- Total and pain free walking distance per individual for PAD patients(Change from baseline up to 13 months)
- Number of participants with individual risk(Up to 13 months)
- Duration of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PAD(Up to 13 months)