UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012667 |
|---|---|
| Receipt number | R000014775 |
| Scientific Title | The epidemiological study of cerebral embolism and venous thromboembolism using a Japanese hospital claims database. |
| Date of disclosure of the study information | 2013/12/24 |
| Last modified on | 2021/07/07 08:44:04 |
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Basic information
Public title
The epidemiological study of cerebral embolism and venous thromboembolism using a Japanese hospital claims database.
Acronym
The epidemiological study of cerebral embolism and venous thromboembolism using a Japanese hospital claims database.
Scientific Title
The epidemiological study of cerebral embolism and venous thromboembolism using a Japanese hospital claims database.
Scientific Title:Acronym
The epidemiological study of cerebral embolism and venous thromboembolism using a Japanese hospital claims database.
Region
| Japan |
Condition
Condition
1, patients with atrial fibrillation
2, patients with cerebral embolism
3, patients undergoing lower extremity orthopedic surgery
4, patients with venous thromboembolism
Classification by specialty
| Medicine in general | Cardiology | Neurology |
| Vascular surgery | Orthopedics | Neurosurgery |
| Cardiovascular surgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate clinical conditions and risk factors related to cerebral embolism and venous thromboembolism using a Japanese hospital claims database.
Basic objectives2
Others
Basic objectives -Others
epidemiological survey
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1, stroke (including cerebral embolism) events, systemic embolic events
2, venous thromboembolic events (deep vein thrombosis, pulmonary thromboembolism)
3, bleeding events
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
1, patients with atrial fibrillation
2, patients with cerebral embolism
3, patients with venous thromboembolism
4, patients undergoing lower extremity orthopedic surgery
Key exclusion criteria
none
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Takuhiro |
| Middle name | |
| Last name | Yamaguchi |
Organization
Biostatistics,
Tohoku University Graduate School of Medicine
Division name
Clinical Research Data Center, Tohoku University Hospital
Zip code
980-8575
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, JAPAN
TEL
022-717-7659
yamaguchi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Kobayashi |
Organization
Linical Co., Ltd
Division name
Corporate planning department
Zip code
532-0003
Address
1-6-1 Miyahara, Yodogawa-ku, Osaka, Japan
TEL
06-6150-2478
Homepage URL
kobayashi-masafumi@linical.co.jp
Sponsor or person
Institute
Clinical Research, Data Center, Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Safety and Risk Management Department, Quality and Safety Management Division, DAIICHI SANKYO CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Medical Data Vision Co., Ltd.
Medical TOUKEI Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai-shi, Miyagi
Tel
022-717-8007
med-kenkyo@bureau.tohoku.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
東北大学病院臨床試験データセンター（宮城県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 24 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000014775
Publication of results
Published
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000014775
Number of participants that the trial has enrolled
69327
Results
See the following document (URL)
1.
https://www.jstage.jst.go.jp/article/jjdi/17/2/17_87/_article/-char/ja/
2.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5381070/
3.
https://www.journal-of-cardiology.com/article/S0914-5087(16)30279-9/fulltext
4.
https://www.journal-of-cardiology.com/article/S0914-5087(16)30289-1/fulltext
5.
https://www.strokejournal.org/article/S1052-3057(17)30606-7/fulltext
Results date posted
| 2021 | Year | 07 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Refer to each document described in "Results"
Participant flow
Refer to each document described in "Results"
Adverse events
Refer to each document described in "Results"
Outcome measures
Refer to each document described in "Results"
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2013 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective study
Management information
Registered date
| 2013 | Year | 12 | Month | 24 | Day |
Last modified on
| 2021 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014775
