UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033283 |
|---|---|
| Receipt number | R000037948 |
| Scientific Title | Safety and efficacy of 4 difference direct oral anticoagulants, dabigatran, rivaroxaban, apixaban and edoxaban in real-world clinical practice: a single center prospective all-comer registry |
| Date of disclosure of the study information | 2018/07/04 |
| Last modified on | 2023/12/18 13:43:54 |
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Basic information
Public title
Safety and efficacy of 4 difference direct oral anticoagulants, dabigatran, rivaroxaban, apixaban and edoxaban in real-world clinical practice: a single center prospective all-comer registry
Acronym
DIRECT registry
Scientific Title
Safety and efficacy of 4 difference direct oral anticoagulants, dabigatran, rivaroxaban, apixaban and edoxaban in real-world clinical practice: a single center prospective all-comer registry
Scientific Title:Acronym
DIRECT registry
Region
| Japan |
Condition
Condition
non-valvular atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present study is to evaluate the safety and effectiveness of 4 different direct oral anticoagulants in Japanese real-world clinical practice.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary safety end point was the occurrence of clinically significant bleeding [a composite of major bleeding according to the International Society on Thrombosis and Haemostasis (ISTH) criteria and any minor bleeding].
The primary efficacy end point was the occurrence of a major adverse cardiovascular event (a composite of death from cardiovascular causes, myocardial infarction, or stroke).
Key secondary outcomes
Secondary endpoints were each individual components of the primary safety and efficacy endpoints.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Non-valvular atrial fibrillation
Key exclusion criteria
None
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Akio |
| Middle name | |
| Last name | Hirata |
Organization
Osaka Police Hospital
Division name
Department of Cardiology
Zip code
543-0035
Address
10-31, Kitayama, Tennoji, Osaka, Japan
TEL
0667716051
ohkohchan@gmail.com
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Sotomi |
Organization
Osaka Police Hospital
Division name
Department of Cardiology
Zip code
543-0035
Address
10-31, Kitayama, Tennoji, Osaka, Japan
TEL
0667716051
Homepage URL
sotomiyohei@gmail.com
Sponsor or person
Institute
Department of Cardiology, Osaka Police Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
IRB, Osaka Police Hospital
Address
10-31, Kitayama, Tennoji, Osaka, Japan
Tel
0667716051
yhiguchi-ja@umin.net
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
| 2018 | Year | 07 | Month | 04 | 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
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2031 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The safety and efficacy of the four different direct oral anticoagulants in patients with non-valvular atrial fibrillation will be evaluated.
Management information
Registered date
| 2018 | Year | 07 | Month | 04 | Day |
Last modified on
| 2023 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037948
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
