UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027754 |
|---|---|
| Receipt number | R000031800 |
| Scientific Title | clinical survery for drug adherence and satisfaction of rivaroxaban in non-valvelar patients with atrial fibrillation |
| Date of disclosure of the study information | 2017/06/15 |
| Last modified on | 2019/06/17 13:30:20 |
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Basic information
Public title
clinical survery for drug adherence and satisfaction of rivaroxaban in non-valvelar patients with atrial fibrillation
Acronym
CHikushi Anti-coagulation Trial for Xarelto
Scientific Title
clinical survery for drug adherence and satisfaction of rivaroxaban in non-valvelar patients with atrial fibrillation
Scientific Title:Acronym
CHikushi Anti-coagulation Trial for Xarelto
Region
| Japan |
Condition
Condition
non-valvelar patients with atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
prospective abservational cohort study for clinical survey for drug adherence and satisfaction of rivsroxaban in non-vslverlar patients with atrial fibrillation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
drug adherence and satisfaction
Key secondary outcomes
Base
Study type
Interventional
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
Xarelto Tablets 15mg once a day
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
non-valvelar patients with atrial fibrillateion
1)newly prescribed
2)exchange from warfarin appropriateness judged by each attending doctor
Key exclusion criteria
1)patient without infurmed consent
2)HD patients or serrese renal failure
3)bleeding symptom
4)more than moderate hepatic dystunction
5)pregnant or suspected
6)in appropriateness judged by attendeing doctor
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Urata |
Organization
Fukuoka University Chikushi Hospital
Division name
Cardiovascular internal medeicine
Zip code
818-8502
Address
1-1-1,Zokumyouin,Chikushino Fukuoka
TEL
092-921-1011
uratah@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Hidenori |
| Middle name | |
| Last name | Urata |
Organization
Fukuoka University Chikushi HOspital
Division name
Cardiovascular internal medicine
Zip code
818-8502
Address
1-1-1,Zokumyouin,Chikushino Fukuoka
TEL
092-921-1011
Homepage URL
uratah@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Chikushi Hospital
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin,Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka University Chikushi Hospital
Address
1-1-1,Zokumyouin,Chikushino Fukuoka
Tel
092-921-1011
noriet@fukuoka-u.ac.jp
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
| 2017 | Year | 06 | Month | 15 | 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
| 2013 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 14 | Day |
Last modified on
| 2019 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031800
