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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000002371
Receipt No. R000002909
Scientific Title Atorva-af prevention study
Date of disclosure of the study information 2009/10/01
Last modified on 2009/08/23

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Basic information
Public title Atorva-af prevention study
Acronym Atorva-af prevention study
Scientific Title Atorva-af prevention study
Scientific Title:Acronym Atorva-af prevention study
Region
Japan

Condition
Condition ischemic heart disease
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluat whether pretreatment with atorvastatin protects against Af after OPAB surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes occurrence of Af
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 preoperative statin treated
Interventions/Control_2 no statin treated
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

Not applicable
Gender Male and Female
Key inclusion criteria statin group:
LDL cho > 100 mg/dL
adminisnistered statin
control group:
LDL cho < 100 mg/dL without statin treatment
Key exclusion criteria preoperative Af
aberrant high level of liver enzyme

disorder muscle

steroid administration
severe renal dysfunction
severe liver dysfunction
past history of severe allergy
Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeo Tedoriya
Organization Showa University
Division name Thoracic and cardiovascular surgery
Zip code
Address 1-5-8, Hatanoda, Shinagawa-ku, Tokyo
TEL 03-3784-8588
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tadamasa Miyauchi
Organization Showa University
Division name Thoracic and cardiovascular surgery
Zip code
Address
TEL 03-3784-8588
Homepage URL
Email miyauchi@med.showa-u.ac.jp

Sponsor
Institute Showa University School of Medicine Thoracic and cardiovascular surgery
Institute
Department

Funding Source
Organization none
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
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
2009 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Date of protocol fixation
2008 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2014 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 08 Month 23 Day
Last modified on
2009 Year 08 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002909

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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