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.
Study Type
OBSERVATIONAL
Enrollment
7,000
Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine
Sendai, Miyagi, Japan
RECRUITINGCombinations of symptomatic stroke (ischemic or hemorrhagic) and systemic embolism
Primary efficacy endpoint
Time frame: up to March/2016
Clinically significant hemorrhagic events (massive hemorrhage in accordance with the ISTH classification)
Primary safety endpoint
Time frame: up to March/2016
Combinations of symptomatic stroke (ischemic or hemorrhagic), systemic embolism, myocardial infarction and cardiovascular death
Secondary efficacy endpoints
Time frame: up to March/2016
Symptomatic ischemic stroke
Secondary efficacy endpoints
Time frame: up to March/2016
Symptomatic hemorrhagic stroke
Secondary efficacy endpoints
Time frame: up to March/2016
Systemic embolism
Secondary efficacy endpoints
Time frame: up to March/2016
Acute myocardial infarction/unstable angina pectoris
Secondary efficacy endpoints
Time frame: up to March/2016
Cardiovascular death
Secondary efficacy endpoints
Time frame: up to March/2016
Deep vein thrombosis/pulmonary thromboembolism
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Secondary efficacy endpoints
Time frame: up to March/2016
Transient ischemic attack
Secondary efficacy endpoints
Time frame: up to March/2016
Interventional/surgical treatment
Secondary efficacy endpoints
Time frame: up to March/2016
All-cause death
Secondary efficacy endpoints
Time frame: up to March/2016
Clinically insignificant hemorrhagic events (hemorrhagic events other than clinically significant hemorrhagic events)
Secondary safety endpoint
Time frame: up to March/2016