Clinical trial NCT02147444: Evaluation of Effectiveness and Safety of Xa Inhibitor for the Prevention of Stroke And Systemic Embolism in a Nationwide Cohort of Japanese Patients Diagnosed as Non-valvular Atrial Fibrillation
Official title: Multi-center, Prospective, Non-interventional, Observational Cohort Study to Investigate Effectiveness and Safety of Rivaroxaban on Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation in Japanese Clinical Practice
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-valvular Atrial Fibrillation
Keywords: Rivaroxaban
Non-valvular atrial fibrillation
NOAC
Xa inhibitor
Lead sponsor: Tohoku University
Sponsor class: OTHER
First posted: 2014-05-26
Enrollment: 7000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Non-valvular atrial fibrillation (In the present study, non-valvular atrial fibrillation refers to atrial fibrillation without a history of prosthetic valve replacement or mitral valve stenosis.)

Brief summary: The efficacy and safety of a novel oral Xa inhibitor for stroke and systemic embolism, namely rivaroxaban, in non-valvular atrial fibrillation patients are evaluated in Japanese clinical practice.


Eligibility criteria: Inclusion Criteria:

Patients who meet all the criteria below

* Patients aged over 20 years
* Patients diagnosed with non-valvular atrial fibrillation
* Patients who are treated or will be treated with rivaroxaban
* Patients from whom written informed consent has been obtained

Exclusion Criteria:

Patients who meet any of the criteria below

* The following patients in whom rivaroxaban is contraindicated for use
* Patients with a history of allergies to the ingredients contained in this drug
* Patients having a hemorrhagic event (intracranial hemorrhage, gastrointestinal hemorrhage or other clinically significant hemorrhagic events)
* Patients having liver disease complicated with coagulation disorder or those having moderate or worse liver disorder (Grade B or C in accordance with the Child-Pugh classification)
* Patients having renal failure (creatinine clearance: \<15 mL/min)
* Women who are or are likely to be pregnant
* Patients who are treated with HIV protease inhibitors (including ritonavir, atazanavir and indinavir)
* Patients who are treated with oral or injectable formulations of azole antifungal drugs (including itraconazole, voriconazole and ketoconazole (excluding fluconazole))

Primary outcomes:
measure: Combinations of symptomatic stroke (ischemic or hemorrhagic) and systemic embolism
timeFrame: up to March/2016
measure: Clinically significant hemorrhagic events (massive hemorrhage in accordance with the ISTH classification)
timeFrame: up to March/2016
Secondary outcomes:
measure: Combinations of symptomatic stroke (ischemic or hemorrhagic), systemic embolism, myocardial infarction and cardiovascular death
timeFrame: up to March/2016
measure: Symptomatic ischemic stroke
timeFrame: up to March/2016
measure: Symptomatic hemorrhagic stroke
timeFrame: up to March/2016
measure: Systemic embolism
timeFrame: up to March/2016
measure: Acute myocardial infarction/unstable angina pectoris
timeFrame: up to March/2016
measure: Cardiovascular death
timeFrame: up to March/2016
measure: Deep vein thrombosis/pulmonary thromboembolism
timeFrame: up to March/2016
measure: Transient ischemic attack
timeFrame: up to March/2016
measure: Interventional/surgical treatment
timeFrame: up to March/2016
measure: All-cause death
timeFrame: up to March/2016
measure: Clinically insignificant hemorrhagic events (hemorrhagic events other than clinically significant hemorrhagic events)
timeFrame: up to March/2016
Other outcomes:
Locations:
city: Sendai
country: Japan
facility: Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine
state: Miyagi
Study officials:
affiliation: Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine
name: Hiroaki Shimokawa, MD, PhD
role: STUDY_CHAIR
References: