CTRI/2021/08/035826尚未招募未知
Rivaroxaban with Aspirin in Stable Cardiovascular Disease: An Observational Study in Indian Patients
Dr Viveka Kumar0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
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研究设计
- 研究类型
- Pms
入排标准
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
研究者
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