NCT03284762

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,216

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 15, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2019

Completed
Last Updated

November 24, 2020

Status Verified

November 1, 2020

Enrollment Period

1.9 years

First QC Date

September 14, 2017

Last Update Submit

November 20, 2020

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • 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: * A fall in hemoglobin 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.

    Up to one year

Secondary Outcomes (6)

  • AEs

    Up to one year

  • SAEs

    Up to one year

  • All-cause mortality

    Up to one year

  • Non-major bleeding events

    Up to one year

  • Symptomatic thromboembolic events

    Up to one year

  • +1 more secondary outcomes

Study Arms (1)

Treatment-naïve NVAF patients in Korea and Taiwan

Patients will be followed according to routine medical practice and the frequency of visits and procedures will be performed under routine conditions. NVAF: Non-valvular atrial fibrillation

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Interventions

Rivaroxaban (Xarelto, BAY59-7939)DRUG

Rivaroxaban is a direct Factor Xa inhibitor. In this non-interventional setting, the prescription and dosing scheme is up to the treatment physician, however, the recommended dosing scheme is 20mg/day (once daily) or 15 mg/day (once daily) in patients with reduced renal function

Treatment-naïve NVAF patients in Korea and Taiwan

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients from Taiwan and Korea visiting doctors in hospitals or medical practices for treatment of atrial fibrillation

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Different facilities

Multiple Locations, South Korea

Location

Different facilities

Multiple Locations, Taiwan

Location

Related Publications (1)

  • Liu PY, Choi EK, Kim TS, Kuo JY, Lee JM, On YK, Park SW, Park HW, Shin DG, Wang L, Yen HW, Lee MH; XaMINA Investigators. XaMINA: A Real-World, Prospective, Observational Study of Treatment-Naive Patients Treated with Rivaroxaban for Stroke Prevention in Atrial Fibrillation in Asia. Adv Ther. 2022 Jul;39(7):3316-3333. doi: 10.1007/s12325-022-02102-8. Epub 2022 May 26.

    PMID: 35616848DERIVED

Related Links

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2017

First Posted

September 15, 2017

Study Start

September 11, 2017

Primary Completion

August 9, 2019

Study Completion

November 20, 2019

Last Updated

November 24, 2020

Record last verified: 2020-11

Locations

TW(1)KR(1)