UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002371 |
|---|---|
| Receipt number | R000002909 |
| Scientific Title | Atorva-af prevention study |
| Date of disclosure of the study information | 2009/10/01 |
| Last modified on | 2009/08/23 23:32:19 |
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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
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
miyauchi@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University School of Medicine Thoracic and cardiovascular surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002909
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
