UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005963 |
|---|---|
| Receipt number | R000002172 |
| Scientific Title | Case-control study of the effect of HMG-CoA reductases on subarachnoid hemorrhage |
| Date of disclosure of the study information | 2011/07/11 |
| Last modified on | 2011/07/11 18:21:34 |
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Basic information
Public title
Case-control study of the effect of HMG-CoA reductases on subarachnoid hemorrhage
Acronym
SAH-Statin Study
Scientific Title
Case-control study of the effect of HMG-CoA reductases on subarachnoid hemorrhage
Scientific Title:Acronym
SAH-Statin Study
Region
| Japan |
Condition
Condition
subarachnoid hemorrhage due to ruptured cerebral aneurysm and unruptured cerebral aneurysm
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the effect of HMG-CoA reductases on rupture of cerebral aneurysms
Basic objectives2
Others
Basic objectives -Others
Cases are patients who suffered from subarachnoid hemorrhage due to ruptured cerebral aneurysms, and controls are patients with unruptured cerebral aneurysms.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Information of cerebral aneurysms and intake of HMG-CoA reductases
Key secondary outcomes
Other clinical information including drug intake other than HMG-CoA reductases
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases are patients who suffer from subarachnoid hemorrhage due to ruptured cerebral aneurysms.
Controls are patients who have unruptured cerebral aneurysms.
Key exclusion criteria
Cerebral aneurysms due to trauma, dissection, infection, autoimmune diseases, hereditary diseases are excluded.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Nozaki |
Organization
Shiga University of Medical Science
Division name
Neurosurgery
Zip code
Address
Seta-Tsukinowa-cho, Otsu
TEL
077-548-2257
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Nozaki |
Organization
Shiga University of Medical Science
Division name
Neurosurgery
Zip code
Address
Seta-Tsukinowa-cho, Otsu
TEL
077-548-2257
Homepage URL
noz@belle.shiga.med.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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
| 2011 | Year | 07 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The risk of subarachnoid hemorrhage may be reduced with the medication of specific drugs.
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
| 2009 | Year | 01 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 10 | Month | 01 | Day |
Other
Other related information
Any side effects have not been observed by now.
Management information
Registered date
| 2011 | Year | 07 | Month | 11 | Day |
Last modified on
| 2011 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002172
