To assess safety and effectiveness of Rivaroxaban(Xarelto)in managing coronary and or symptomatic peripheral artery disease in Indian Patients
- Conditions
- Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
- Registration Number
- CTRI/2022/01/039597
- Lead Sponsor
- Bayer Zydus Pharma Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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
bleeding).
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
practice
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of participants with haemorrhagic events and complications [ Time Frame: Up to 13 months ] <br/ ><br>Consisting of minor and major bleeding events. The major bleeding complications are collected according to the International Society on Thrombosis and Haemostasis (ISTH) criteria as a composite of fatal bleeding, symptomatic bleeding into a critical organ (such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome), bleeding into surgical site requiring reoperation, bleeding leading to hospitalizationTimepoint: upto 13 months
- Secondary Outcome Measures
Name Time Method