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Xarelto on Prevention of Stroke and Non-central Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation in China: A Non-interventional Study (XASSURE)

This study is currently recruiting participants.
Verified November 2017 by Bayer
Sponsor:
ClinicalTrials.gov Identifier:
NCT02784717
First Posted: May 27, 2016
Last Update Posted: November 9, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Bayer
  Purpose
This non-interventional field study will investigate rivaroxaban under clinical practice conditions for stroke prevention and for prevention of non-CNS systemic embolism in patients with non-valvular atrial fibrillation in China.

Condition Intervention
Stroke Drug: Rivaroxaban (Xarelto, BAY 59-7939)

Study Type: Observational
Study Design: Observational Model: Case-Only
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 China: A Non-interventional Study.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Number of Major bleeding events [ Time Frame: Up to 30 months ]

    Major bleeding events, collected as serious or non serious adverse events and defined as overt bleeding associated with:

    1. a fall in haemoglobin of ≥2 g/dL, or
    2. a transfusion of ≥2 units of packed red blood cells or whole blood, or
    3. occurrence at a critical site (intracranial, intra-spinal, intraocular, pericardial, intra articular, intra-muscular with compartment syndrome, retroperitoneal), or
    4. death


Secondary Outcome Measures:
  • Number of Symptomatic thromboembolic events [ Time Frame: Up to 30 months ]
    Collected as serious or non-serious adverse events

  • Number of Non-major bleeding [ Time Frame: Up to 30 months ]
    Collected as serious or non-serious adverse events and defined as all bleeding events that do not fall in the category of major bleedings

  • Treatment satisfaction questionnaire [ Time Frame: Up to 30 months ]
  • Adverse event and serious adverse event percentage in the different atrial fibrillation risk factor categories [ Time Frame: Up to 30 months ]
  • Number of each reason for any switch from or interruption of rivaroxaban treatment [ Time Frame: Up to 30 months ]

    If the patients switch from or interruption of rivaroxaban treatment, patients or physicians will be asked by several questions about the reasons of the switch and interruption, and collected in CRF. The reasons will be described by frequency distributions.

    Reason choice as below:

    1. Patient choice 2. Insufficient therapeutic effect 3. Adverse event 4. Surgery 5. Dentistry 6. Renal function change



Estimated Enrollment: 6000
Actual Study Start Date: May 11, 2016
Estimated Study Completion Date: August 30, 2021
Estimated Primary Completion Date: June 30, 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Rivaroxaban (Xarelto, BAY 59-7939)
Female and male patients, who are at least 18 years of age with a diagnosis of non-valvular atrial fibrillation will be enrolled after the decision for a pharmacologic prophylaxis with rivaroxaban to prevent stroke or non-CNS systemic embolism has been made.
Drug: Rivaroxaban (Xarelto, BAY 59-7939)
Decision regarding dose and duration of treatment made at the discretion of the attending investigator.

Detailed Description:
3000 patients will be provided with free drug.It is planned to have an interim analysis(IA) when 3000 patients are enrolled (cut off day is the 3000th patient completed at least 3 months follow-up visit). To end or continue enrolling patients will be decided based on the IA result and the evaluation comments from CFDA.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Female and male patients, who are at least 18 years of age with a diagnosis of non-valvular atrial fibrillation will be enrolled after the decision for a pharmacologic prophylaxis with rivaroxaban within approved indication to prevent stroke or non-CNS systemic embolism has been made.
Criteria

Inclusion Criteria:

  • Female and male patients ≥ 18 years of age diagnosed with non-valvular atrial fibrillation
  • Patients for whom the decision to initiate treatment with rivaroxaban to prevent stroke or non-CNS systemic embolism was made as per investigator's routine treatment practice

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02784717


Contacts
Contact: Bayer Clinical Trials Contact (+) 1-888-8422937 clinical-trials-contact@bayer.com

Locations
China
Recruiting
HangZhou, China
Sponsors and Collaborators
Bayer
Janssen Scientific Affairs, LLC
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02784717     History of Changes
Other Study ID Numbers: 16819
XA1207CN ( Other Identifier: Company internal )
First Submitted: April 27, 2016
First Posted: May 27, 2016
Last Update Posted: November 9, 2017
Last Verified: November 2017

Keywords provided by Bayer:
rivaroxaban,
non-interventional,
atrial fibrillation,
stroke prevention,

Additional relevant MeSH terms:
Stroke
Atrial Fibrillation
Embolism
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Embolism and Thrombosis
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants