Rivaroxaban with Aspirin in Stable Cardiovascular Disease: An Observational Study in Indian Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Percentage risk reduction in the risk of a composite of myocardial infarction, stroke, or cardiovascular death in subjects with CAD
研究概览
简要总结
Novel oral anticoagulants 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 rivaroxaban along with aspirin in patients with stable CAD. This will be a prospective observational study to compare the real world effectiveness and safety of patients with rivaroxaban with aspirin therapy vs patients on aspirin therapy alone. Up to 200 patients from single site (Max Hospital, Saket, Delhi) will be enrolled and followed for efficacy and safety outcomes for a period of 52 weeks.
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
- •1.Willing and able to provide written informed consent 2.Age >18 years, either gender and known case stable coronary artery disease (CAD) 3.Patient at high risk for atherothrombosis 4.Patient eligible for dual pathway therapy (Rivaroxaban plus Aspirin) based on clinical judgement and receiving the same.
排除标准
- •1.Clinically considered high risk of bleeding 2.Presence of gastrointestinal bleed 3.Stroke within 1 month or any history of hemorrhagic or lacunar stroke 4.Severe heart failure with known ejection fraction <30% or New York Heart Association (NYHA) class III or IV symptoms 5.Estimated glomerular filtration rate (eGFR)<15 mL/min 6.Clinically requiring dual antiplatelet therapy, other non-aspirin antiplatelet therapy, or oral anticoagulant therapy 7.History of hypersensitivity or known contraindication for rivaroxaban, aspirin, or excipients, if applicable.
- •8.Systemic treatment with strong inhibitors of both CYP 3A4 and p-glycoprotein (P-gp) (e.g., systemic azole antimycotics, such as ketoconazole, and human immunodeficiency virus [HIV]-protease inhibitors, such as ritonavir), or strong inducers of CYP 3A4, i.e. rifampicin, rifabutin, phenobarbital, phenytoin, and carbamazepine.
- •9.Subjects who are pregnant, breastfeeding, or are of childbearing potential, and sexually active and not practicing an effective method of birth control.
结局指标
主要结局
Percentage risk reduction in the risk of a composite of myocardial infarction, stroke, or cardiovascular death in subjects with CAD
时间窗: 1 Year
次要结局
- The primary safety outcome will be a composite of:(Fatal bleeding, and/or)