UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036769 |
|---|---|
| Receipt number | R000041896 |
| Scientific Title | Efficacy and Safety Evaluation According to Plasma Concentration Measurement on Direct Oral Anticoagulation Using Factor-Xa Inhibitors for Non-valvular Atrial Fibrillation on Multicenter Study |
| Date of disclosure of the study information | 2019/05/17 |
| Last modified on | 2024/07/03 21:07:39 |
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Basic information
Public title
Efficacy and Safety Evaluation According to Plasma Concentration Measurement on Direct Oral Anticoagulation Using Factor-Xa Inhibitors for Non-valvular Atrial Fibrillation on Multicenter Study
Acronym
SETtu DOAC Registry(SET DOAC Registry)
Scientific Title
Efficacy and Safety Evaluation According to Plasma Concentration Measurement on Direct Oral Anticoagulation Using Factor-Xa Inhibitors for Non-valvular Atrial Fibrillation on Multicenter Study
Scientific Title:Acronym
SETtu DOAC Registry(SET DOAC Registry)
Region
| Japan |
Condition
Condition
Non-valvular atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the efficacy and safety of medication management by drug blood concentration monitoring
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Bleeding and thrombosis events and blood DOAC concentration from the start of medication to 12 months
Key secondary outcomes
Measurement values of molecular markers and coagulation tests from the start of medication to 12 months
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Non-valvular atrial fibrillation
Key exclusion criteria
Patients judged by the attending physician as inappropriate for this study
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Michihiro |
| Middle name | |
| Last name | Suwa |
Organization
Hokusetsu General Hospital
Division name
Clinical laboratory division
Zip code
569-0852
Address
6-24 Kitayanagawa-cho Takatsuki-city Osaka-fu
TEL
072-696-2121
suwa-mic@hokusetsu-hp.jp
Public contact
Name of contact person
| 1st name | Michihiro |
| Middle name | |
| Last name | Suwa |
Organization
Hokusetsu General Hospital
Division name
Clinical laboratory division
Zip code
569-0852
Address
6-24 Kitayanagawa-cho Takatsuki-city Osaka-fu
TEL
072-696-2121
Homepage URL
suwa-mic@hokusetsu-hp.jp
Sponsor or person
Institute
Hokusetsu General Hospital
Clinical laboratory division
Institute
Department
Personal name
Funding Source
Organization
Sysmex corporation
Hemostasis Business Development
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokusetsu General Hospital
Address
6-24 Kitayanagawa-cho Takatsuki-city Osaka-fu
Tel
072-696-2121
suwa-mic@hokusetsu-hp.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
| 2019 | Year | 05 | Month | 17 | Day |
Related information
URL releasing protocol
https://www.hokusetsu-hp.jp/hospital/opt-out.html
Publication of results
Unpublished
Result
URL related to results and publications
https://www.hokusetsu-hp.jp/hospital/opt-out.html
Number of participants that the trial has enrolled
950
Results
The concentration range (90%tile, 5% - 95%) at the peak period of each DOAC was calculated.
Correlation between blood drug concentration and other test items
Confirm clinical findings, blood drug concentration, and each consideration item
Results date posted
| 2024 | Year | 07 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients taking DOACs in NVAF
Participant flow
The attending physician obtains informed consent from the patient.
Adverse events
None
Outcome measures
bleeding/thrombus
Blood drug concentration
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluation of cut-off level in blood drug concentration
cut-off level
Evaluation of time course in blood drug concentration
Evaluation of coagulation related markers (Fibrin monomer complex, CWA parameters)
Management information
Registered date
| 2019 | Year | 05 | Month | 16 | Day |
Last modified on
| 2024 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041896
