Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Asia (XANAP)
This study is currently recruiting participants.
Verified June 2013 by Bayer
Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01750788
First received: December 13, 2012
Last updated: June 11, 2013
Last verified: June 2013
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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:
Genetics Home Reference related topics:
familial atrial fibrillation
MedlinePlus related topics:
Atrial Fibrillation
Drug Information available for:
Rivaroxaban
U.S. FDA Resources
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: | 5500 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | February 2016 |
| Estimated Primary Completion Date: | July 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
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 | |
| Not yet recruiting | |
| Many Locations, Indonesia | |
| Korea, Republic of | |
| Recruiting | |
| Many Locations, Korea, Republic of | |
| Malaysia | |
| Not yet recruiting | |
| Many Locations, Malaysia | |
| Philippines | |
| Not yet recruiting | |
| Many Locations, Philippines | |
| Singapore | |
| Recruiting | |
| Many Locations, Singapore | |
| Taiwan | |
| Recruiting | |
| Many Locations, Taiwan | |
| Thailand | |
| Not yet recruiting | |
| Many Locations, Thailand | |
| Vietnam | |
| Not yet 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: | June 11, 2013 |
| 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 |
ClinicalTrials.gov processed this record on June 17, 2013