Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Asia (XANAP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01750788
First received: December 13, 2012
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

This is an international observational study in patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism.


Condition Intervention
Atrial Fibrillation
Drug: Rivaroxaban (Xarelto, BAY59-7939)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Xarelto® on Prevention of Stroke and Non-central Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation in Asia: A Non-interventional Study

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Adjudicated major bleeding events [ Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later ] [ Designated as safety issue: Yes ]
  • Safety variables will be summarized using descriptive statistics based on adverse events collection [ Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • All cause mortality [ Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later ] [ Designated as safety issue: Yes ]
  • Adjudicated symptomatic thromboembolic events [ Time Frame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2300
Study Start Date: January 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Rivaroxaban (Xarelto, BAY59-7939)
Patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism. Decision regarding dose and duration of treatment made at the discretion of the attending investigator.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with a diagnosis of non-valvular atrial fibrillation who start treatment with rivaroxaban to prevent stroke or non-CNS systemic embolism

Criteria

Inclusion Criteria:

  • Female and male patients ≥ 18 years of age with a diagnosis of non-valvular atrial fibrillation who start treatment with rivaroxaban to prevent stroke or non-CNS (Central Nervous System) systemic embolism, and who consent to participate in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01750788

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
Hong Kong
Recruiting
Many Locations, Hong Kong
India
Not yet recruiting
Many Locations, India
Indonesia
Recruiting
Many Locations, Indonesia
Korea, Republic of
Recruiting
Many Locations, Korea, Republic of
Malaysia
Recruiting
Many Locations, Malaysia
Pakistan
Recruiting
Many Locations, Pakistan
Philippines
Recruiting
Many Locations, Philippines
Singapore
Recruiting
Many Locations, Singapore
Taiwan
Recruiting
Many Locations, Taiwan
Thailand
Recruiting
Many Locations, Thailand
Vietnam
Recruiting
Many Locations, Vietnam
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01750788     History of Changes
Other Study ID Numbers: 16371, XA1205
Study First Received: December 13, 2012
Last Updated: August 18, 2014
Health Authority: India: Drugs Controller General of India
Indonesia: National Agency of Drug and Food Control
Indonesia: Ethics Committee
Korea: Food and Drug Administration
Korea: Institutional Review Board
Malaysia: Institutional Review Board
Pakistan: Research Ethics Committee
Philippines : Food and Drug Administration
Singapore: Domain Specific Review Boards
Singapore: Health Sciences Authority
Taiwan: Institutional Review Board
Thailand: Food and Drug Administration
Thailand: Ministry of Public Health
Vietnam: Ministry of Health

Keywords provided by Bayer:
Stroke
Embolism
Atrial Fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Stroke
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Rivaroxaban
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2014