UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046323 |
|---|---|
| Receipt number | R000052860 |
| Scientific Title | Anti-factor Xa assay in patients with atrial fibrillation |
| Date of disclosure of the study information | 2021/12/08 |
| Last modified on | 2024/06/10 09:25:43 |
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Basic information
Public title
Anti-factor Xa assay in patients with atrial fibrillation
Acronym
Anti-factor Xa assay in patients with atrial fibrillation
Scientific Title
Anti-factor Xa assay in patients with atrial fibrillation
Scientific Title:Acronym
Anti-factor Xa assay in patients with atrial fibrillation
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to elucidate the anti-factor Xa activity in three factor Xa inhibitors and the relationship between anti-factor Xa activity and cardiovascular events.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
anti-factor Xa activity
Key secondary outcomes
Cardiovascular events after 1 year
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Twice blood examination, edoxaban.
Interventions/Control_2
Twice blood examination, apixaban.
Interventions/Control_3
Twice blood examination, Rivaroxaban.
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
AF patients who have taken factor Xa inhibitors.
Key exclusion criteria
AF patients who have side effect of factor Xa inhibitors.
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Arimoto |
Organization
Yamagata University School of Medicine
Division name
Department of cardiology
Zip code
990-9585
Address
Iida-nishi 2-2-2, Yamagata
TEL
023-628-5302
t-arimoto@med.id.yamagata-u.ac.jp
Public contact
Name of contact person
| 1st name | Takanori |
| Middle name | |
| Last name | Arimoto |
Organization
Yamagata University School of Medicine
Division name
Department of cardiology
Zip code
990-9585
Address
Iida-nishi 2-2-2, Yamagata
TEL
023-628-5302
Homepage URL
t-arimoto@med.id.yamagata-u.ac.jp
Sponsor or person
Institute
Yamagata University School of Medicine
Department of cardiology
Institute
Department
Personal name
Funding Source
Organization
Yamagata University School of Medicine
Department of cardiology
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
Yamagata University School of Medicine
Address
Department of cardiology
Tel
023-628-5302
t-arimoto@med.id.yamagata-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
| 2021 | Year | 12 | Month | 08 | 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
| 2021 | Year | 12 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
About 100 patients were enrolled.
Management information
Registered date
| 2021 | Year | 12 | Month | 08 | Day |
Last modified on
| 2024 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052860
