UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020761 |
|---|---|
| Receipt number | R000023962 |
| Scientific Title | The serum anti-Xa activity monitoring |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2016/04/12 08:36:34 |
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Basic information
Public title
The serum anti-Xa activity monitoring
Acronym
The serum anti-Xa activity monitoring
Scientific Title
The serum anti-Xa activity monitoring
Scientific Title:Acronym
The serum anti-Xa activity monitoring
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is to evaluate the feasibility of monitoring the anti-Xa activity and other coagulation tests.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship among the coagulation tests, bleeding events, and thrombogenic events
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
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
blood sampling
once
< 10 cc
during the period of the clinical trial
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with non-vitamin K antagonist oral anticoagulants
Key exclusion criteria
Equivalent to the drug indications
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiji Takatsuki |
Organization
Keio University School of Medicine
Division name
Department of Cardiology
Zip code
Address
35 Shinanomachi Shinjuku-ku
TEL
0333531211
seiji.takatsuki@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takehiro Kimura |
Organization
Keio University School of Medicine
Division name
Department of Cardiology
Zip code
Address
35 Shinanomachi Shinjuku-ku
TEL
0333531211
Homepage URL
kimura@z7.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine
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
| 2016 | Year | 04 | Month | 01 | 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 | 11 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 27 | Day |
Last modified on
| 2016 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023962
