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 (EXPAND)

Tohoku University

Status: Unknown

Conditions: Non-valvular Atrial Fibrillation

Study type: Observational

Funder types: Other

Identifiers

NCT02147444

EXPAND study

UMIN000009376 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 7,000 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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))

Trial design

7,000 participants in 1 patient group

Non-valvular atrial fibrillation

Description:

* Patients diagnosed with non-valvular atrial fibrillation * Patients who are treated or will be treated with rivaroxaban