Non-valvular Atrial Fibrillation
Conditions
Keywords
Rivaroxaban, Non-valvular atrial fibrillation, NOAC, Xa inhibitor
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.
Interventions
None listed
Sponsors
Tohoku University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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))
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Combinations of symptomatic stroke (ischemic or hemorrhagic) and systemic embolism | up to March/2016 | Primary efficacy endpoint |
| Clinically significant hemorrhagic events (massive hemorrhage in accordance with the ISTH classification) | up to March/2016 | Primary safety endpoint |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptomatic hemorrhagic stroke | up to March/2016 | Secondary efficacy endpoints |
| Systemic embolism | up to March/2016 | Secondary efficacy endpoints |
| Acute myocardial infarction/unstable angina pectoris | up to March/2016 | Secondary efficacy endpoints |
| Cardiovascular death | up to March/2016 | Secondary efficacy endpoints |
| Combinations of symptomatic stroke (ischemic or hemorrhagic), systemic embolism, myocardial infarction and cardiovascular death | up to March/2016 | Secondary efficacy endpoints |
| Transient ischemic attack | up to March/2016 | Secondary efficacy endpoints |
| Interventional/surgical treatment | up to March/2016 | Secondary efficacy endpoints |
| All-cause death | up to March/2016 | Secondary efficacy endpoints |
| Clinically insignificant hemorrhagic events (hemorrhagic events other than clinically significant hemorrhagic events) | up to March/2016 | Secondary safety endpoint |
| Deep vein thrombosis/pulmonary thromboembolism | up to March/2016 | Secondary efficacy endpoints |
| Symptomatic ischemic stroke | up to March/2016 | Secondary efficacy endpoints |
Countries
Japan
Contacts
Primary ContactKoji Fukuda, M.D., Ph. D
Outcome results
None listed