Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Asia (XANAP)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01750788 |
Recruitment Status
:
Completed
First Posted
: December 17, 2012
Last Update Posted
: September 21, 2017
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Sponsor:
Bayer
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer
Tracking Information | ||||
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First Submitted Date | December 13, 2012 | |||
First Posted Date | December 17, 2012 | |||
Last Update Posted Date | September 21, 2017 | |||
Actual Study Start Date | January 13, 2013 | |||
Actual Primary Completion Date | October 12, 2015 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
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Original Primary Outcome Measures |
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Change History | Complete list of historical versions of study NCT01750788 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Asia | |||
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 | |||
Brief Summary | 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. | |||
Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
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 | |||
Condition | Atrial Fibrillation | |||
Intervention | 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. |
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Study Groups/Cohorts | Group 1
Intervention: Drug: Rivaroxaban (Xarelto, BAY59-7939) |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
2297 | |||
Original Estimated Enrollment |
5500 | |||
Actual Study Completion Date | October 12, 2015 | |||
Actual Primary Completion Date | October 12, 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Hong Kong, India, Indonesia, Korea, Republic of, Malaysia, Pakistan, Philippines, Singapore, Taiwan, Thailand, Vietnam | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01750788 | |||
Other Study ID Numbers | 16371 XA1205 ( Other Identifier: Company internal ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Bayer | |||
Study Sponsor | Bayer | |||
Collaborators | Janssen Research & Development, LLC | |||
Investigators |
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PRS Account | Bayer | |||
Verification Date | September 2017 |