Xarelto on Prevention of Stroke and Non-Central Nervous Systemic Embolism in Renally Impaired Korean Patients With Non-valvular Atrial Fibrillation (XARENAL)
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|ClinicalTrials.gov Identifier: NCT03746301|
Recruitment Status : Recruiting
First Posted : November 19, 2018
Last Update Posted : September 13, 2019
|Condition or disease||Intervention/treatment|
|Non-valvular Atrial Fibrillation (NVAF)||Drug: Rivaroxaban(Xarelto,BAY 59-7939)|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Xarelto® on Prevention of Stroke and Non-Central Nervous Systemic (CNS) Embolism in Renally Impaired Korean Patients With Non-valvular Atrial Fibrillation (NVAF)|
|Actual Study Start Date :||December 3, 2018|
|Estimated Primary Completion Date :||December 1, 2020|
|Estimated Study Completion Date :||June 15, 2021|
Patients will be followed according to routine medical practice and the frequency of visits and procedures will be performed under routine conditions.
Drug: Rivaroxaban(Xarelto,BAY 59-7939)
10mg, 15mg and 20 mg film-coated tablets
- Incidence proportion of major bleeding [ Time Frame: Up to 12 months ]
Incidence proportion of major bleeding events collects as serious or non-serious AEs 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
- Occurrence of AEs and SAEs [ Time Frame: Up to 12 months ]
- Occurrence of all-cause mortality [ Time Frame: Up to 12 months ]
- Occurrence of Non-major bleeding [ Time Frame: Up to 12 months ]Non-major bleeding events collected as SAEs or non-serious AEs and defined as all bleeding events that do not fall in the category of major bleeding.
- Incidence proportion of Symptomatic thromboembolic events [ Time Frame: Up to 12 months ]Symptomatic thromboembolic events collected as SAEs or non-serious AEs.
- Days of rivaroxaban treatment [ Time Frame: Up to 12 months ]Start of rivaroxaban therapy and, if applicable, stop of rivaroxaban therapy(in case of treatment discontinuation, switch, or interruption, the reason will be recorded)
- The change in creatinine clearance from baseline [ Time Frame: At month 3,6,9 and 12 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03746301
|Contact: Bayer Clinical Trials Contact||(+)1-888-84 firstname.lastname@example.org|
|Korea, Republic of|
|Multiple Locations, Korea, Republic of|