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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013308
Receipt No. R000015523
Scientific Title Effect of apixaban for anti-atherosclerotic response in atrial fibrillation patients
Date of disclosure of the study information 2014/03/02
Last modified on 2015/12/07

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Basic information
Public title Effect of apixaban for anti-atherosclerotic response in atrial fibrillation patients
Acronym Effect of apixaban for anti-atherosclerotic response in atrial fibrillation patients
Scientific Title Effect of apixaban for anti-atherosclerotic response in atrial fibrillation patients
Scientific Title:Acronym Effect of apixaban for anti-atherosclerotic response in atrial fibrillation patients
Region
Japan

Condition
Condition atrial fibrillation
Classification by specialty
Medicine in general Cardiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the effect of apixaban for anti-atherosclerotic actions
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Change of inflammatory cytokine,hs-CRP,PTX3,TM
Transition of blood coagulation and fibrinolysis
Key secondary outcomes Evaluation of atherosclerotic actions by ABI/CAVI
Evaluation of atherosclerotic plaque volume by carotid artery echo

Base
Study type

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Prescirbe apixaban 5mg twice daily for 6 months.
Patients who correspond to low dose standard pescirbe apixaban 2.5mg twice daily.
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 nonvalvular atrial fibrillation
Key exclusion criteria High risk for bleeding
Renal failure
severe infection and trauma,perioperaion
History of allergy to apixaban
Ineligible in the opinion of investigators
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ichiro Michishita
Organization Yokohama Sakae Kyosai Hospital
Division name Division of Cardiology,Department of Internal Medicine
Zip code
Address 132 Katsura-cho,Sakae-ku,Yokohama,Kanagawa,Japan
TEL 045-891-2171
Email i-michishita@yokohamasakae.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiromasa Katoh
Organization Yokohama Sakae Kyosai Hospital
Division name Division of Cardiology,Department of Internal Medicine
Zip code
Address 132 Katsura-cho,Sakae-ku,Yokohama,Kanagawa,Japan
TEL 045-891-2171
Homepage URL
Email hiromasa_im2_m@yahoo.co.jp

Sponsor
Institute Yokohama Sakae Kyosai Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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
2014 Year 03 Month 02 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 Completed
Date of protocol fixation
2014 Year 02 Month 13 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 03 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
2016 Year 08 Month 31 Day
Date analysis concluded
2016 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 03 Month 02 Day
Last modified on
2015 Year 12 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015523

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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