Trial Condition(s):
Atrial Fibrillation
Xarelto on prevention of stroke and noncentral nervous system systemic embolism in treatment-naïve Asian patients with non-valvular atrial fibrillation (XaMINA)
Bayer Identifier:
18981
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Different facilities Multiple Locations, Taiwan, China | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Different facilities Multiple Locations, South Korea | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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:
1
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.Timeframe: Up to one year
Secondary Outcome
- AEsAll events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"Timeframe: Up to one year
- SAEsAll events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"Timeframe: Up to one year
- All-cause mortalityAll events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"Timeframe: Up to one year
- Non-major bleeding eventsAll events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"Timeframe: Up to one year
- Symptomatic thromboembolic eventsAll events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"Timeframe: Up to one year
- Start of rivaroxaban therapy and, if applicable, stop of rivaroxaban therapyStart date and stop date will be collected to receive information on drug persistenceTimeframe: Up to one year
Additional Information
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