UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053756 |
|---|---|
| Receipt number | R000061287 |
| Scientific Title | A Meta-Analysis of Off-Label Low Dose Versus Recommended Standard Dose of Direct Oral Anticoagulants in the Japanese Non-valvular Atrial Fibrillation Patients |
| Date of disclosure of the study information | 2024/06/20 |
| Last modified on | 2024/03/01 19:24:28 |
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Basic information
Public title
A Meta-Analysis of Off-Label Low Dose Versus Recommended Standard Dose of Direct Oral Anticoagulants in the Japanese Non-valvular Atrial Fibrillation Patients
Acronym
A Meta-Analysis of Off-Label Low Dose Versus Recommended Standard Dose of Direct Oral Anticoagulants in the Japanese Non-valvular Atrial Fibrillation Patients
Scientific Title
A Meta-Analysis of Off-Label Low Dose Versus Recommended Standard Dose of Direct Oral Anticoagulants in the Japanese Non-valvular Atrial Fibrillation Patients
Scientific Title:Acronym
A Meta-Analysis of Off-Label Low Dose Versus Recommended Standard Dose of Direct Oral Anticoagulants in the Japanese Non-valvular Atrial Fibrillation Patients
Region
| Japan |
Condition
Condition
Non-valvular atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Western guidelines for atrial fibrillation continue to adopt a cautious stance on the use of off-label low-dose direct oral anticoagulants (DOACs). Given the higher risk of bleeding complications among East Asians compared to Western populations, the applicability of Western guidelines to clinical practice in Japan is questionable. This meta-analysis examines trials that include Japanese patients with non-valvular atrial fibrillation, comparing the safety and efficacy of off-label versus recommended DOAC doses.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Stroke or systemic embolism. 2. Major bleeding
Key secondary outcomes
Non-major clinically relevant bleeding
Base
Study type
Others,meta-analysis etc
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
1. Registry studies that included patients with non-valvular atrial fibrillation who were administered DOACs.
2. Studies reporting the incidence of major bleeding and stroke/systemic embolism in patient groups administered with recommended and off-label low doses of DOACs.
3. Studies conducted in Japan.
Key exclusion criteria
Studies that do not report the incidence of either major bleeding or stroke/systemic embolism in patient groups administered with recommended doses and off-label low doses of DOACs.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Akinori |
| Middle name | |
| Last name | Sairaku |
Organization
National Hospital Organization Higashihiroshima Medical Center
Division name
Cardiology
Zip code
7390041
Address
513 Jike, Saijo-cho, Higashihiroshima
TEL
0824232176
rjrgw059@ybb.ne.jp
Public contact
Name of contact person
| 1st name | Akinori |
| Middle name | |
| Last name | Sairaku |
Organization
National Hospital Organization Higashihiroshima Medical Center
Division name
Cardiology
Zip code
7390041
Address
513 Jike, Saijo-cho, Higashihiroshima
TEL
0824232176
Homepage URL
rjrgw059@ybb.ne.jp
Sponsor or person
Institute
National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
individual payment
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
Research Committee of Higashihiroshima Medical Center
Address
513 Jike, Saijo-cho, Higashihiroshima
Tel
0824232176
shiranita.emi.vy@mail.hosp.go.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
| 2024 | Year | 06 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The present meta-analysis is conducted on the basis of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Registry studies that included predominantly Japanese patients with non-valvular atrial fibrillation who were administered DOACs are included in the analyses. Literature is systematically searched using PubMed (MEDLINE). The following clinical outcomes are compared between patients treated with off-label low-dose and those with on-label standard dose of DOACs. The primary effective outcome is stroke or systemic thromboembolism. The primary safety outcome is major bleeding, as defined in the statement of the International Society on Thrombosis and Haemostasis (ISTH). We also assess clinically relevant non-major bleeding, defined as a bleeding event that is neither a major bleed as defined by the ISTH nor a non-clinically consequential minor bleeding event.
Management information
Registered date
| 2024 | Year | 03 | Month | 01 | Day |
Last modified on
| 2024 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061287
