MedPath

A study to evaluate safety and effectiveness of Rivaroxaban (Xarelto®) forPrevention of Stroke and Systemic Embolism in IndianPatients with Non-valvular Atrial Fibrillation (NVAF)

Phase 4
Conditions
Health Condition 1: I489- Unspecified atrial fibrillation and atrial flutter
Registration Number
CTRI/2019/09/021158
Lead Sponsor
Bayer Zydus Pharma Private Limited
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Closed to Recruitment of Participants
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

• Patient should be an adult female or male, >=18 years of age;

• Patient should be diagnosed with NVAF and initiated with rivaroxaban treatment for

prevention of stroke or systemic embolism per investigatorâ??s routine treatment practice;

• Patient should not have received rivaroxaban in the past;

• Patient/patientâ??s legally acceptable representative should be willing to provide written

informed consent.

Exclusion Criteria

1. Patient has contraindications to receive rivaroxaban therapy according to local prescribing

information;

2. Patient is receiving anticoagulant therapy for indication other than NVAF and that needs to

be continued as per discretion of treating physician;

3. Patient is participating in an investigational program with interventions outside of routine

clinical practice.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath