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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
April 27, 2016
May 27, 2016
November 9, 2017
May 11, 2016
June 30, 2021   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT02784717 on ClinicalTrials.gov Archive Site
  • 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

Same as current
Not Provided
Not Provided
 
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
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.
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.
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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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.
Stroke
Drug: Rivaroxaban (Xarelto, BAY 59-7939)
Decision regarding dose and duration of treatment made at the discretion of the attending investigator.
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.
Intervention: Drug: Rivaroxaban (Xarelto, BAY 59-7939)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
6000
August 30, 2021
June 30, 2021   (Final data collection date for primary outcome measure)

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:

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Bayer Clinical Trials Contact (+) 1-888-8422937 clinical-trials-contact@bayer.com
China
 
 
NCT02784717
16819
XA1207CN ( Other Identifier: Company internal )
No
Not Provided
Not Provided
Bayer
Bayer
Janssen Scientific Affairs, LLC
Study Director: Bayer Study Director Bayer
Bayer
November 2017