A phase IV study to investigate the safety andeffectiveness of Rivaroxaban(Xarelto) 2.5mg(BID plusAcetylsalicylic Acid (ASA) 75 mg OD in Indian patientswith coronary and or symptomatic peripheral artery disease - RIVACA

Bayer Zydus Pharma Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年4月3日

试验速览

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•1.Adult (>=18 years) female or male patient
•2. Diagnosis of CAD or PAD
•3. Decision to treat the patient with Rivaroxaban 2.5mg [BID] , co-administered with ASA
•75mg[OD], 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 has been made by the investigator
•4. Patient is willing to participate in the study (signed informed consent).

•1. Patients with haemoglobin level less than 10 gm/dl
•2. Patients with clinically significant active bleeding (e.g., intracranial bleeding, gastrointestinal
•3. Patients with hepatic disease which is associated with coagulopathy leading to a clinically
•relevant bleeding risk
•4. In patients with severe renal impairment (Cr Cl <15 ml/min)
•5. Patients with a history of GI bleeding
•6. CAD or PAD patients with previous haemorrhagic or lacunar stroke
•7. History of hypersensitivity or known contraindication for rivaroxaban, aspirin
•8. Patients who will be treated with chronic anticoagulation therapy other than rivaroxaban 2.5
•mg given for CAD/PAD.
•9. Patient is a pregnant women and nursing mother
•Participation in an investigational program with interventions outside of routine clinical

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