UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018290 |
|---|---|
| Receipt number | R000021170 |
| Scientific Title | Registry study of stroke patients with oral anticoagulation therapy in Kyoto |
| Date of disclosure of the study information | 2015/07/13 |
| Last modified on | 2021/01/15 09:30:46 |
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Basic information
Public title
Registry study of stroke patients with oral anticoagulation therapy in Kyoto
Acronym
KOACS registry
Scientific Title
Registry study of stroke patients with oral anticoagulation therapy in Kyoto
Scientific Title:Acronym
KOACS registry
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Cardiology | Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical background, treatment and prognosis of stroke patients taking oral anticoagulants (OAC) in Kyoto
Basic objectives2
Others
Basic objectives -Others
Registration and follow-up
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
National Institute of Health Stroke Scale (NIHSS) score on admission
modified Rankin Scale (mRS) at hospital discharge
Key secondary outcomes
type of ischemic stroke on admission
type of hemorrhagic stroke on admission
invasive treatment
expansion of intracranial bleeding
recurrence of ischemic stroke
mRS at 3 mo, 1y, 2y, 3y
stroke or all-cause death during follow-up
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
stroke patients who were prescribed oral anticoagulants
Key exclusion criteria
Bleeding due to trauma
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masaharu |
| Middle name | |
| Last name | Akao |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Department of Cardiology
Zip code
612-8555
Address
1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto
TEL
075-641-9161
kyoto.oac.stroke@gmail.com
Public contact
Name of contact person
| 1st name | Masaharu |
| Middle name | |
| Last name | Akao |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Department of Cardiology
Zip code
612-8555
Address
1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto
TEL
075-641-9161
Homepage URL
https://edmsweb16.eps.co.jp/edmsweb/
kyoto.oac.stroke@gmail.com
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Kyoto Medical Center
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
National Hospital Organization Kyoto Medical Center
Address
1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto
Tel
075-641-9161
akao@kuhp.kyoto-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
国立病院機構京都医療センター(京都府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
150
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
severity of stroke according to OAC drugs
Management information
Registered date
| 2015 | Year | 07 | Month | 13 | Day |
Last modified on
| 2021 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021170
