UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011129 |
|---|---|
| Receipt number | R000013038 |
| Scientific Title | Effect of rivaroxaban for anti-atherosclerotic response in atrial fibrillation patients |
| Date of disclosure of the study information | 2013/07/05 |
| Last modified on | 2013/07/05 19:22:17 |
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Basic information
Public title
Effect of rivaroxaban for anti-atherosclerotic response in atrial fibrillation patients
Acronym
Effect of rivaroxaban for anti-atherosclerotic response in atrial fibrillation patients
Scientific Title
Effect of rivaroxaban for anti-atherosclerotic response in atrial fibrillation patients
Scientific Title:Acronym
Effect of rivaroxaban 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 rivaroxaban 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
Transition of blood coagulation and fibrinolysis
Key secondary outcomes
Evaluation of IMT by carotid artery echo
Evaluation of atherosclerotic plaque volume and character
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
Pescribe rivaroxaban15mg or 10mg once daily , according to renal function
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
nonvalvular atrial fibrillation
Key exclusion criteria
High risk for bleeding
Liver dysfunction
Renal failure
Pregnancy
severe infection and trauma, perioperation
Treatment with HIV protease inhibitors
Treatment with azole antifungal agents
History of allergy to rivaroxaban
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 Michshita |
Organization
Yokohama Sakae Kyosai Hospital
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
Address
132 Katsura-cho, Sakae-ku, Yokohama, 247-8581, Japan
TEL
045-891-2171
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sei Nakata |
Organization
Yokohama Sakae Kyosai Hospital
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
Address
132 Katsura-cho, Sakae-ku, Yokohama, 247-8581, Japan
TEL
045-891-2171
Homepage URL
i-michishita@yokohamasakae.jp
Sponsor or person
Institute
Yokohama Sakae Kyosai Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 07 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 10 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 05 | Day |
Last modified on
| 2013 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013038
