check_circleStudy Completed

Stroke

Bayer Identifier:

16819

ClinicalTrials.gov Identifier:

NCT02784717

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial 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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • -NA

Trial summary

Enrollment Goal
3055
Trial Dates
May 2016 - September 2019
Phase
N/A
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
HangZhou, China

Primary Outcome

  • Number of Major bleeding events
    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
    date_rangeTime Frame:
    Up to 30 months
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Number of Symptomatic thromboembolic events
    Collected as serious or non-serious adverse events
    date_rangeTime Frame:
    Up to 30 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of Non-major bleeding
    Collected as serious or non-serious adverse events and defined as all bleeding events that do not fall in the category of major bleedings
    date_rangeTime Frame:
    Up to 30 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Treatment satisfaction questionnaire
    date_rangeTime Frame:
    Up to 30 months
    enhanced_encryption
    Safety Issue:
    No
  • Adverse event and serious adverse event percentage in the different atrial fibrillation risk factor categories
    date_rangeTime Frame:
    Up to 30 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of each reason for any switch from or interruption of rivaroxaban treatment
    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
    date_rangeTime Frame:
    Up to 30 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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