CTRI/2022/01/039597
Active, not recruiting
Phase 4
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
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
- Sponsor
- Bayer Zydus Pharma Pvt Ltd
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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).
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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