UMIN-CTR Clinical Trial

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
Email	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
Email	kobayashi-masafumi@linical.co.jp

Sponsor
Institute	Clinical Research, Data Center, Tohoku University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014775