UMIN-CTR Clinical Trial

Basic information
Public title	Japan Thrombosis Registry for Atrial fibrillation, Coronary (Myocardial Infarction) or Cerebrovascular (Cerebral Infarction / Cerebral hemorrhage) Events
Acronym	Japan Thrombosis Registry for Atrial fibrillation, or Cerebrovascular Events (J-TRACE)
Scientific Title	Japan Thrombosis Registry for Atrial fibrillation, Coronary (Myocardial Infarction) or Cerebrovascular (Cerebral Infarction / Cerebral hemorrhage) Events
Scientific Title:Acronym	Japan Thrombosis Registry for Atrial fibrillation, or Cerebrovascular Events (J-TRACE)
Region	Japan

Condition
Condition	stroke, myocardial infarction, atrial fibrillation
Classification by specialty	Medicine in general Cardiology Neurology Surgery in general Vascular surgery Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Recurrence rate of Coronary or Cerebrovascular Events
Basic objectives2	Others
Basic objectives -Others	Recurrence rate of Coronary or Cerebrovascular Events
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Recurrence rate of Coronary or Cerebrovascular 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	20 years-old <
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	stroke , myocardial infarction, atrial fibrillation
Key exclusion criteria	In-patient due to acute phase target disease(s)
Target sample size	15000

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasuo Ikeda
Organization	Department of Medicine, Keio University School of Medicine
Division name	Department of Medicine
Zip code
Address	35 Shinanomachi, Shinjuku, tokyo, japan
TEL	03-3353-1211
Email

Public contact
Name of contact person	1st name Middle name Last name Shinya Goto
Organization	Department of Medicine, Tokai University School of Medicine
Division name	Department of Medicine
Zip code
Address	143 Shimokasuya, Isehara, Kanagawa 259-1143, Japan
TEL	0463-93-1121
Homepage URL	http://www.j-trace.com
Email	shinichi@is.icc.u-tokai.ac.jp

Sponsor
Institute	Society for the J-TRACE
Institute
Department

Funding Source
Organization	The Japan Heart Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	None
Name of secondary funder(s)	None

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2005 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results	CV even rate in stable outpatients recruited in the J-TRACE registry was 3.53 events per 100 person-years (95% confidence interval [CI]: 3.11-3.99).
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	2004 Year 11 Month 20 Day
Date of IRB
Anticipated trial start date	2005 Year 01 Month 01 Day
Last follow-up date	2008 Year 06 Month 01 Day
Date of closure to data entry	2008 Year 06 Month 01 Day
Date trial data considered complete	2008 Year 06 Month 01 Day
Date analysis concluded	2008 Year 06 Month 01 Day

Other
Other related information	J-Trace is the observation study to clarify the incidence of atherothrombosis and thrombotic disease caused by atrial fibrillation.

Management information
Registered date	2005 Year 09 Month 12 Day
Last modified on	2014 Year 04 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000263

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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