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NCT Number: NCT02784717

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.

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Key information

Conditions

Stroke Arrhythmias, Cardiac Atrial Fibrillation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hangzhou, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • NA

Treatment and study plan

Rivaroxaban (Xarelto, BAY 59-7939)

Drug

Decision regarding dose and duration of treatment made at the discretion of the attending investigator.

Primary outcomes

  1. 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:

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

Secondary outcomes

  1. Number of Symptomatic thromboembolic events

    Time frame: Up to 30 months

    Collected as serious or non-serious adverse events

  2. 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

  3. Treatment satisfaction questionnaire

    Time frame: Up to 30 months

  4. Adverse event and serious adverse event percentage in the different atrial fibrillation risk factor categories

    Time frame: Up to 30 months

  5. 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:

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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Scientific Affairs, LLC

Registry information

Official study 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

Acronym: XASSURE

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 27, 2016
Registry last updated
Sep 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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