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 - EXPAND study

Tohoku University School of Medicine0 sites7,000 target enrollmentNovember 21, 2012

Overview

Phase: 未知
Intervention: Not specified
Conditions: on-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.)
Sponsor: Tohoku University School of Medicine
Enrollment: 7000
Status: Recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

November 21, 2012

End Date

March 31, 2016

Last Updated

2 years ago

Study Type

Observational

Sex

All

Sponsor

•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))