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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014775


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name