check_circleStudy Completed

Atrial fibrillation

Bayer Identifier:

18981

ClinicalTrials.gov Identifier:

NCT03284762

EudraCT Number:

Not Available

EU CT Number:

Not Available
Xarelto on prevention of stroke and noncentral nervous system systemic embolism in treatment-naïve Asian patients with non-valvular atrial fibrillation

Trial purpose

The purpose of the study is to collect additional information of Xarelto treatment in routine clinical practice. Patients affected by atrial fibrillation and who will get Xarelto as a prophylactic treatment against stroke and systemic embolism (Stroke Prevention in Atrial Fibrillation) will be observed.

Key Participants Requirements

Sex

All

Age

19 - N/A
  • - Female and male patients aged 19 years or older (Korea) and aged 20 years or older (Taiwan)
    - Diagnosis of NVAF
    - Patients for whom the decision to initiate treatment with rivaroxaban is made as per physician’s routine treatment practice
    - Treatment naïve regarding stroke prevention for atrial fibrillation
    - Signed informed consent

  • - Contraindications for rivaroxaban according to the local market authorization/summary of product characteristics (SmPC)
    - Patients participating in an investigational program with interventions outside of routine clinical practice

Trial summary

Enrollment Goal
1216
Trial Dates
September 2017 - November 2019
Phase
Phase 4
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Different facilitiesMultiple Locations, Taiwan
Completed
Different facilitiesMultiple Locations, Korea, Republic Of

Primary Outcome

  • Major bleeding events, collected as Serious Adverse Events (SAEs) or non-serious Adverse Events (AEs)
    Major bleeding events, collected as SAEs or non-serious AEs and defined as overt bleeding associated with: o A fall in hemoglobin of ≥2 g/dL, or o A transfusion of ≥2 units of packed red blood cells or whole blood, or o Occurrence at a critical site (intracranial, intra-spinal, intraocular, pericardial, intra articular, intra-muscular with compartment syndrome, retroperitoneal), or o Death.
    date_rangeTime Frame:
    Up to one year

Secondary Outcome

  • AEs
    All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"
    date_rangeTime Frame:
    Up to one year
  • SAEs
    All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"
    date_rangeTime Frame:
    Up to one year
  • All-cause mortality
    All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"
    date_rangeTime Frame:
    Up to one year
  • Non-major bleeding events
    All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"
    date_rangeTime Frame:
    Up to one year
  • Symptomatic thromboembolic events
    All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"
    date_rangeTime Frame:
    Up to one year
  • Start of rivaroxaban therapy and, if applicable, stop of rivaroxaban therapy
    Start date and stop date will be collected to receive information on drug persistence
    date_rangeTime Frame:
    Up to one year

Trial design

Xarelto® on prevention of stroke and noncentral nervous system systeMIc embolism in treatment Naïve Asian patients with non-valvular atrial fibrillation
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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