UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014230 |
|---|---|
| Receipt number | R000016537 |
| Scientific Title | Intracranial hemorrhage during the novel oral anticoagulants treatment: a nationwide, multicenter, retrospective cohort study in Japan |
| Date of disclosure of the study information | 2014/06/15 |
| Last modified on | 2015/03/18 12:23:10 |
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Basic information
Public title
Intracranial hemorrhage during the novel oral anticoagulants treatment: a nationwide, multicenter, retrospective cohort study in Japan
Acronym
Intracranial hemorrhage during the novel oral anticoagulants treatment: a nationwide, multicenter, retrospective cohort study in Japan
Scientific Title
Intracranial hemorrhage during the novel oral anticoagulants treatment: a nationwide, multicenter, retrospective cohort study in Japan
Scientific Title:Acronym
Intracranial hemorrhage during the novel oral anticoagulants treatment: a nationwide, multicenter, retrospective cohort study in Japan
Region
| Japan |
Condition
Condition
Patients with atrial fibrillation who received the antithrombotic therapy using novel oral anticoagulants
Classification by specialty
| Medicine in general | Cardiology | Neurology |
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the association between Intracranial hemorrhage and novel oral anticoagulants in patients with atrial fibrillation using a nationwide questionnaire survey in Japan.
Basic objectives2
Others
Basic objectives -Others
Patients with atrial fibrillation should be treated by the antithrombotic therapy to prevent ischemic stroke. Recently, a novel anticoagulants (NOACs) are introduced and substitute for warfarin because of their safety and efficacy. However, it is still unclear that the current status of the risk of stroke and intracranial hemorrhage in patients with atrial fibrillation who taking NOACs.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Intracranial hemorrhage
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
We conducted a nation-wide survey using a questionnaire to clarify the current status of intracranial hemorrhage during novel oral anticoagulants therapy in patients with atrial fibrillation in Japan.
We sent a questionnaire to the directors of 240 acute stroke hospitals in Japan.
Key exclusion criteria
Doctors who did not agree the present questionnaire survey
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazumi Kimura |
Organization
Kawasaki Medical School
Division name
Department of Stroke Medicine
Zip code
Address
577 Matsushima, Kurashiki Okayama 701-0192, Japan
TEL
0864621111
kimurak@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Supervisor: Kazumi Kimura (office: Naoki Saji) |
Organization
Kawasaki Medical School
Division name
Department of Stroke Medicine
Zip code
Address
577 Matsushima, Kurashiki Okayama 701-0192, Japan
TEL
0864621111
Homepage URL
stroke3@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Department of Stroke Medicine, Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
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
Address
Tel
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
| 2014 | Year | 06 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/circj/advpub/0/advpub_CJ-14-1209/_pdf
Number of participants that the trial has enrolled
Results
Background:We conducted a multicenter retrospective cohort study to elucidate the characteristics of intracranial hemorrhage (ICH) in patients with atrial fibrillation treated with non-vitamin K antagonist oral anticoagulants (NOACs).
Methods and Results:We sent a questionnaire to the directors of 241 stroke centers in Japan to establish the clinical characteristics of NOAC-associated cerebral hemorrhage (CH), including hematoma size, hematoma enlargement (HE) and in-hospital mortality of patients treated in their institutions. We undertook a literature review to establish the clinical characteristics of warfarin-associated CH and compared these with our data. We received 174 responses (72.2%), of which 67 (38.5%) gave anonymous details of 130 eligible patients (male, 67.7%; mean age, 77.3+-8.3 years, in-hospital mortality rate, 11.5%). We judged that 87 of the 130 patients had presented with CH: one-fifth had taken antiplatelet drugs. We found that the incidences of HE and mortality in the 87 patients presenting with NOAC-associated CH were lower than would have been expected in those with warfarin-associated CH (17% vs. 26%, and 16% vs. 35%, respectively).
Conclusions:More than half the stroke center directors who responded to our questionnaire had not experienced cases of NOAC-associated ICH. Compared with warfarin, NOACs appear to present a lower risk of HE and death in patients with atrial fibrillation who develop CH.
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
| 2014 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 07 | Month | 31 | Day |
Other
Other related information
For further details, please see the article.
Management information
Registered date
| 2014 | Year | 06 | Month | 11 | Day |
Last modified on
| 2015 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016537
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