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临床试验/CTRI/2021/08/035826
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

暂无简介。

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

发起方
Dr Viveka Kumar

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