UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009376
Receipt No. R000010958
Scientific 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
Date of disclosure of the study information 2012/11/21
Last modified on 2013/07/11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public 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
Acronym EXPAND study
Scientific 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
Scientific Title:Acronym EXPAND study
Region
Japan

Condition
Condition 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.)
Classification by specialty
Cardiology Neurology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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 clinical practice.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Primary efficacy endpoint
- Combinations of symptomatic stroke (ischemic or hemorrhagic) and systemic embolism
Primary safety endpoint
- Clinically significant hemorrhagic events (massive hemorrhage in accordance with the ISTH classification)
Key secondary outcomes Secondary efficacy endpoints
- Combinations of symptomatic stroke (ischemic or hemorrhagic), systemic embolism, myocardial infarction and cardiovascular death
- Symptomatic ischemic stroke
- Symptomatic hemorrhagic stroke
- Systemic embolism
- Acute myocardial infarction/unstable angina pectoris
- Cardiovascular death
- Deep vein thrombosis/pulmonary thromboembolism
- Transient ischemic attack
- Interventional/surgical treatment
- All-cause death
Secondary safety endpoint
- Clinically insignificant hemorrhagic events (hemorrhagic events other than clinically significant hemorrhagic events)

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who meet all the criteria below
1) Patients aged over 20 years
2) Patients diagnosed with non-valvular atrial fibrillation
3) Patients who are treated or will be treated with rivaroxaban
4) Patients from whom written informed consent has been obtained
Key exclusion criteria 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))
Target sample size 7000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Shimokawa
Organization Tohoku University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Japan 980-8574
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Mebix, Inc.
Division name Clinical Research Division
Zip code
Address Akasaka Intercity, 1-11-44 Akasaka, Minato-ku, Tokyo, Japan 107-0052
TEL 03-6229-8936
Homepage URL http://www.captool.jp/expand/
Email expand@mebix.co.jp

Sponsor
Institute Tohoku University School of Medicine
Institute
Department

Funding Source
Organization Bayer Yakuhin, Ltd.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 21 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2012 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A randomized, double-blind, comparative study (Study ROCKET AF) was performed overseas using 14,264 non-valvular atrial fibrillation patients and warfarin as a control drug. The results of this study suggest that rivaroxaban is not inferior to warfarin in prevention of stroke and is equivalent to warfarin in safety.
In Japan, Study J-ROCKET AF was performed using 1,280 Japanese non-valvular atrial fibrillation patients. The results of this study also suggest that rivaroxaban is not inferior to warfarin in safety and that even though the power is low, rivaroxaban is effective in preventing ischemic stroke.

Management information
Registered date
2012 Year 11 Month 21 Day
Last modified on
2013 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010958

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.