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

Non-valvular Atrial Fibrillation Clinical Trial

— EXPAND  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02147444
• Other study ID #: EXPAND study
• Secondary ID: UMIN000009376
• Status: Recruiting
• Phase: N/A
• First received: May 12, 2014
• Last updated: May 21, 2014
• Start date: November 2012

Study information

• Verified date: May 2014
• Source: Tohoku University
• Contact: Koji Fukuda, M.D., Ph. D
• Phone: +81-22-717-7153
• Email: fukuda[@]cardio.med.tohoku.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7000
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Non-valvular Atrial Fibrillation

Locations

Country	Name	City	State
Japan	Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine	Sendai	Miyagi

Sponsors (1)

Lead Sponsor	Collaborator
Tohoku University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combinations of symptomatic stroke (ischemic or hemorrhagic) and systemic embolism	Primary efficacy endpoint	up to March/2016	Yes
Primary	Clinically significant hemorrhagic events (massive hemorrhage in accordance with the ISTH classification)	Primary safety endpoint	up to March/2016	Yes
Secondary	Combinations of symptomatic stroke (ischemic or hemorrhagic), systemic embolism, myocardial infarction and cardiovascular death	Secondary efficacy endpoints	up to March/2016	Yes
Secondary	Symptomatic ischemic stroke	Secondary efficacy endpoints	up to March/2016	Yes
Secondary	Symptomatic hemorrhagic stroke	Secondary efficacy endpoints	up to March/2016	Yes
Secondary	Systemic embolism	Secondary efficacy endpoints	up to March/2016	Yes
Secondary	Acute myocardial infarction/unstable angina pectoris	Secondary efficacy endpoints	up to March/2016	Yes
Secondary	Cardiovascular death	Secondary efficacy endpoints	up to March/2016	Yes
Secondary	Deep vein thrombosis/pulmonary thromboembolism	Secondary efficacy endpoints	up to March/2016	Yes
Secondary	Transient ischemic attack	Secondary efficacy endpoints	up to March/2016	Yes
Secondary	Interventional/surgical treatment	Secondary efficacy endpoints	up to March/2016	Yes
Secondary	All-cause death	Secondary efficacy endpoints	up to March/2016	Yes
Secondary	Clinically insignificant hemorrhagic events (hemorrhagic events other than clinically significant hemorrhagic events)	Secondary safety endpoint	up to March/2016	Yes

External Links

•   EXPAND study home page