INdian Real world EvidenCe Of Rivaroxaban use in coronary artery Disease – A prospective observational cohort study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 10
- 主要终点
- Comparison of net clinical benefit between rivaroxaban with antiplatelet therapy group and antiplatelet therapy alone group.
研究概览
简要总结
Direct oral anticoagulants (DOACs) are used to prevent thrombosis in several cardiac contexts such as atrial fibrillation, deep vein thrombosis etc. FDA in 2018, approved rivaroxaban for reduction of major adverse cardiovascular events in patients with chronic coronary artery disease (CAD) or peripheral arterial disease (PAD).The COMPASS published convincing evidence that supports the use of aspirin plus rivaroxaban in patients with stable coronary artery disease. This will be a prospective observational study to compare the real world effectiveness and safety of patients with rivaroxaban with antiplatelet therapy vs patients on antiplatelet therapy alone. Up to 1000 patients from multiple sites across India will be enrolled and followed for efficacy and safety outcomes for a period of 1 year. product) with antiplatelet therapy vs patients on antiplatelet therapy only.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Age >18 years, either gender having a diagnosis of coronary artery disease and meeting the following additional criteria a.
- •Taking antiplatelet therapy for coronary artery disease or peripheral artery disease b.
- •Having ≥2 vascular beds affected or eligible to take an oral anticoagulant therapy
- •Willing to provide written informed consent and for follow up of one year from the date of registration.
排除标准
- •Patients having a diagnosis of atrial fibrillation (valvular or non-valvular) prior to or at the time of index acute coronary event or diagnosis.
- •Patients on high doses of newer oral anticoagulants.
- •â‰¥10mg per day.
- •Patients on vitamin K antagonist for any reason.
- •Patients not likely to cooperate for data collection and follow up – investigator’s decision.
结局指标
主要结局
Comparison of net clinical benefit between rivaroxaban with antiplatelet therapy group and antiplatelet therapy alone group.
时间窗: 1 year
Net Clinical Benefit will be a composite of effectiveness (reduction in incidence of cardiovascular death, stroke, MI) and safety (life threatening or fatal bleeding)
时间窗: 1 year
次要结局
- Change in quality of life from baseline to 1 year assessed using SF-36 questionnaire.(1 year)
- Effectiveness of rivaroxaban with antiplatelet therapy vs antiplatelet therapy alone in reducing the compose outcomes (stroke, myocardial infarction, cardiovascular death)(1 year)
- Non inferiorityof rivaroxaban (Exafib) vs rivaroxaban (reference drug) on net clinical benefit(1 year)
- Incidence of major bleeding between rivaroxaban with antiplatelet therapy vs antiplatelet therapy alone(1 year)
- Net clinical benefit will be compared between the 2 groups (rivaroxaban with antiplatelet therapyvs antiplatelet therapy alone) based on age group (less than 65 years vs more than 65 years); prior PCI, presence,or absence of comorbidities such as heart failure, diabetes mellitus, MI.(1 year)