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)

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

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 Overview

• Status: Unknown
• Conditions: Non-valvular Atrial Fibrillation

• Study Type: Observational
• Enrollment (Anticipated): 7000

Contacts and Locations

• Study Contact: Name: Koji Fukuda, M.D., Ph. D; Phone Number: +81-22-717-7153; Email: fukuda@cardio.med.tohoku.ac.jp

Study Locations

• Japan
  • Miyagi
    • Sendai, Miyagi, Japan, 980-6574
      • Recruiting
      • Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine
      • Contact: Koji Fukuda, MD, PhD; Phone Number: +81-22-717-7153; Email: fukuda@cardio.med.tohoku.ac.jp
      • Principal Investigator: Hiroaki Shimokawa, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.)

Description

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))

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Non-valvular atrial fibrillation; Patients diagnosed with non-valvular atrial fibrillation; Patients who are treated or will be treated with rivaroxaban

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Combinations of symptomatic stroke (ischemic or hemorrhagic) and systemic embolism	Primary efficacy endpoint	up to March/2016
Clinically significant hemorrhagic events (massive hemorrhage in accordance with the ISTH classification)	Primary safety endpoint	up to March/2016

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Combinations of symptomatic stroke (ischemic or hemorrhagic), systemic embolism, myocardial infarction and cardiovascular death	Secondary efficacy endpoints	up to March/2016
Symptomatic ischemic stroke	Secondary efficacy endpoints	up to March/2016
Symptomatic hemorrhagic stroke	Secondary efficacy endpoints	up to March/2016
Systemic embolism	Secondary efficacy endpoints	up to March/2016
Acute myocardial infarction/unstable angina pectoris	Secondary efficacy endpoints	up to March/2016
Cardiovascular death	Secondary efficacy endpoints	up to March/2016
Deep vein thrombosis/pulmonary thromboembolism	Secondary efficacy endpoints	up to March/2016
Transient ischemic attack	Secondary efficacy endpoints	up to March/2016
Interventional/surgical treatment	Secondary efficacy endpoints	up to March/2016
All-cause death	Secondary efficacy endpoints	up to March/2016
Clinically insignificant hemorrhagic events (hemorrhagic events other than clinically significant hemorrhagic events)	Secondary safety endpoint	up to March/2016

Collaborators and Investigators

• Sponsor: Tohoku University

Publications and helpful links

Helpful Links

• EXPAND study home page

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: May 12, 2014
• First Submitted That Met QC Criteria: May 21, 2014
• First Posted (Estimate): May 26, 2014

Study Record Updates

• Last Update Posted (Estimate): May 26, 2014
• Last Update Submitted That Met QC Criteria: May 21, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Rivaroxaban; NOAC; Non-valvular atrial fibrillation; Xa inhibitor
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Arrhythmias, Cardiac; Embolism; Atrial Fibrillation
• Other Study ID Numbers: EXPAND study; UMIN000009376 (Other Identifier: UMIN)