UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043250 |
|---|---|
| Receipt number | R000049358 |
| Scientific Title | Relationship between plasma concentration of direct oral anticoagulants and clinical prognosis |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2023/01/21 10:45:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Relationship between plasma concentration of direct oral anticoagulants and clinical prognosis
Acronym
Relationship between plasma concentration of direct oral anticoagulants and clinical prognosis
Scientific Title
Relationship between plasma concentration of direct oral anticoagulants and clinical prognosis
Scientific Title:Acronym
Relationship between plasma concentration of direct oral anticoagulants and clinical prognosis
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between plasma concentration of direct oral anti-coagulants and clinical prognosis
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma concentration of direct oral anti-coagulants and clinical prognosis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
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
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
To measure plasma concentration of direct oral anti-coagulants
Interventions/Control_2
Relationship between plasma concentration of direct oral anti-coagulants and clinical prognosis
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
Adult patients taking any of the DOACs, apixaban, dabigatran, edoxaban, or rivaroxaban were included.
People who have agreed to participate in the research.
Key exclusion criteria
People who have not agreed to participate in the research.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Maekawa |
Organization
Hamamatsu University School of Medicine
Division name
Internal Medicine III
Zip code
431-3192
Address
1-20-1 handayama, higashiku, Hamamatsu
TEL
053-435-2356
ymaekawa@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yuichiro |
| Middle name | |
| Last name | Maekawa |
Organization
Hamamatsu University School of Medicine
Division name
Internal Medicine III
Zip code
431-3192
Address
1-20-1 handayama, higashiku, Hamamatsu
TEL
0534352356
Homepage URL
rsato@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
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
Clinical Research Review Board of Hamamatsu University School of Medicine
Address
1-20-1 handayama, higashiku, Hamamatsu
Tel
053-435-2680
rinri@hama-med.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 | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 10 | 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
Management information
Registered date
| 2021 | Year | 02 | Month | 04 | Day |
Last modified on
| 2023 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049358
