Trial Condition(s):

Non-valvular Atrial fibrillation (NVAF)

A study to evaluate the safety and effectiveness of Rivaroxaban (Xarelto) for prevention of stroke and systemic embolism in Indian patients with Non-valvular Atrial Fibrillation (NVAF) (XARIN)

Bayer Identifier:

20387

ClinicalTrials.gov Identifier:

NCT03887780

EudraCT Number:

Not Available

Recruiting

Trial Purpose

This study is planned to collect prospective data and evaluate the safety and effectiveness of rivaroxaban for the prevention of stroke and systemic embolism in Indian patients with NVAF when used in clinical practice under real-life conditions.
The study will be conducted in routine clinical practice settings.
Approximately 1000 patients from India will be enrolled in this study. Patients will be observed for maximum period of 12 months after the start of Xarelto treatment or until it is no longer possible (e.g. lost to follow-up, death, withdrawal) before the end of the observation period.
The decision by the investigator to start with of Xarelto must be independent of the inclusion of a patient to the study.

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 investigator’s routine treatment practice;
- Patient should not have received rivaroxaban in the past; 
- Patient/patient’s legally acceptable representative should be willing to provide written informed consent.
Exclusion Criteria
- Patient has contraindications to receive rivaroxaban therapy according to local prescribing information;
- Patient is receiving anticoagulant therapy for indication other than NVAF and that needs to be continued as per discretion of treating physician;
- Patient is participating in an investigational program with interventions outside of routine clinical practice.

Trial Summary

Enrollment Goal
1000
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Batra Heart Centre

Delhi, India, 110062

Status
Recruiting
 
Locations

Shree Mahavir Health & Medical Society Shri Bachubhai Dahyab

Surat, India, 395001

Status
Not yet recruiting
 
Locations

Apollo Gleneagles Hospital Limited

Kolkata, India, 700054

Status
Not yet recruiting
 
Locations

Batra Hospital and Medical Research Centre (BHMRC)

New Delhi, India, 110062

Status
Not yet recruiting
 
Locations

Apollo Hospitals

Chennai, India, 600006

Status
Not yet recruiting
 
Locations

Divine Heart and Multispeciality Hospital

Lucknow, India, 226010

Status
Not yet recruiting
 
Locations

Fortis Hospital Bangalore

Bengaluru, India, 560076

Status
Not yet recruiting
 
Locations

Anand Multispeciality Hospital

Vadodara, India, 390016

Status
Not yet recruiting
 
Locations

M. S. Ramaiyah Medical College Hospital

Bangalore, India, 560054

Status
Not yet recruiting
 
Locations

Sri Ramachandra Institute of Higher Education and Research

Chennai, India, 600116

Status
Not yet recruiting
 
Locations

Zydus Hospitals and Healthcare Research Private Limited

Ahmedabad, India, 380054

Status
Not yet recruiting
 
Locations

Krishna Institute Of Medical Science

Secunderabad, India, 500003

Status
Not yet recruiting
 
Locations

Paritosha Foundation

Mumbai, India, 400086

Status
Not yet recruiting
 
Locations

Yashoda Hospitals, Hyderabad

Hyderabad, India, 500082

Status
Not yet recruiting
 
Locations

Eternal Hospital

Jaipur, India, 302017

Status
Not yet recruiting
 
Locations

Columbia Asia Referral Hospital Yeshwanthpur

Bangalore, India, 560055

Status
Not yet recruiting
 
Locations

MIOT International

Chennai, India, 600089

Status
Not yet recruiting
 
Locations

Bhaktivedanta Hospital & Research Institute

Thane, India, 401107

Status
Not yet recruiting
 
Locations

Lisie Hospital

Ernakulam, India, 682018

Status
Not yet recruiting
 
Locations

Fortis Hospital

Mohali, India, 160062

Status
Not yet recruiting
 
Locations

Fortis Flt. Lt. Rajan Dhall Hospital

New Delhi, India, 110070

Status
Not yet recruiting
 
Locations

Fortis Hospital

West-Mumbai, India, 400078

Status
Not yet recruiting
 
Locations

Vijan Hospital & Research Centre

Nashik, India, 422005

Status
Not yet recruiting
 
Locations

Joshi Hospital

Pune, India, 411004

Status
Not yet recruiting
 
Locations

Dr. B. L. Kapur Memorial Hospital

New Delhi, India, 110005

Status
Not yet recruiting
 
Locations

Apollo Hospitals

Mumbai, India, 400614

Status
Not yet recruiting
 
Locations

HCG Hospitals, Ahmedabad

Ahmedabad, India, 380006

Status
Not yet recruiting
 

Trial Design