UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050585 |
|---|---|
| Receipt number | R000057081 |
| Scientific Title | An extended study in the clinical evaluation of direct oral anticoagulants: DIRECT-Extend study |
| Date of disclosure of the study information | 2023/03/15 |
| Last modified on | 2026/09/16 10:31:02 |
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Basic information
Public title
An extended study in the clinical evaluation of direct oral anticoagulants
Acronym
DIRECT-Extend study
Scientific Title
An extended study in the clinical evaluation of direct oral anticoagulants: DIRECT-Extend study
Scientific Title:Acronym
DIRECT-Extend study
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Number of AF (atrial fibrillation) patients treated with direct oral anticoagulants is becoming larger. This study will comprehensively analyze the large database which consists of three large-scale registries, and establish the real-world evidences.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
all-cause death, myocardial infarction, stroke, bleeding, gastrointestinal symptoms, heart failure hospitalization, C-reactive protein, catheter ablation
Key secondary outcomes
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 AF patients treated with DOAC
Key exclusion criteria
Patients who are considered inappropriate to include in the study by physicians.
Target sample size
6900
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Sakata |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3640
sakata.yasushi.med@osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Sotomi |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3640
Homepage URL
sotomi.yohei.med@osaka-u.ac.jp
Sponsor or person
Institute
Japan Science and Technology Agency
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka Police Hospital, Nihon university hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Clinical Research Review Committee
Address
2-2 Yamadaoka, Suita, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-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
| 2023 | Year | 03 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-22K16073/
Number of participants that the trial has enrolled
7553
Results
We established the DIRECT-Extend Registry by integrating the DIRECT Registry, SAKURA-AF Registry, and Osaka University Hospital database to generate generalizable real-world evidence on DOAC use in Japan. The registry includes 7,553 patients receiving anticoagulant therapy across diverse clinical settings. Multiple studies have been conducted using this database, with findings presented at EuroPCR 2024 and JCS 2025 and several related articles published.
Results date posted
| 2026 | Year | 09 | Month | 16 | Day |
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
| 2022 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2031 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 09 | Month | 16 | Day |
Other
Other related information
Merged analysis of the 3 large datasets
Management information
Registered date
| 2023 | Year | 03 | Month | 15 | Day |
Last modified on
| 2026 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057081
