UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031704 |
|---|---|
| Receipt number | R000035364 |
| Scientific Title | Registration research on changes in LDL cholesterol in patients with acute cerebral infarction |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2019/03/30 19:17:56 |
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Basic information
Public title
Registration research on changes in LDL cholesterol in patients with acute cerebral infarction
Acronym
Registration research on changes in LDL cholesterol in patients with acute cerebral infarction
Scientific Title
Registration research on changes in LDL cholesterol in patients with acute cerebral infarction
Scientific Title:Acronym
Registration research on changes in LDL cholesterol in patients with acute cerebral infarction
Region
| Japan |
Condition
Condition
acute cerebral infarction
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There are reports that prognosis improving effect can be obtained by administering statin to patients with acute cerebral infarction, and we had conducted ASSORT trial on the basis of those reports. However, there was no significant difference in the prognostic improvement effect after 90 days due to early internal statin in patients with acute cerebral infarction. Therefore, RCTs using a PCSK9 inhibitor were planned, considering whether administration of PCSK9 inhibitor having stronger LDL cholesterol lowering effect than statin would give effect of improving prognosis. However, there is no data that administered PCSK9 inhibitor to patients with acute cerebral infarction, and the transition of its LDL cholesterol level is unknown. So we planned this study to see how differences exist in the transition of LDL cholesterol level in the group administered statin and PCSK 9 inhibitor and the group administered only statin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
changes of LDL cholesterol level until 14 days from admission
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
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
In patients with acute stage cerebral infarction, patients with serum LDL cholesterol at hospitalization level of 70 mg / dl or higher and who are not orally administered before hospitalization will take internal statin in the early stage of admission. If the LDL cholesterol level of the next morning is still above 70 mg / dl, further PCSK9 inhibitor should be administered.
Blood sampling is done at hospitalization (day 0), on day 1, day 2, day 3, day 5, day 7, day 14
Interventions/Control_2
In patients with acute stage cerebral infarction, patients with serum LDL cholesterol at hospitalization level of 70 mg / dl or more and who are not orally administered before hospitalization will take internal statin in the early stage of admission, and continuing only that.
Extract blood collection data of the past record.
Interventions/Control_3
In patients with acute cerebral infarction, PCSK9 inhibitor is administered early after hospitalization for patients who had serum LDL cholesterol level at admission of 70 mg / dl or more and had been taken statin before hospitalization.
Blood sampling is done at hospitalization (day 0), on day 1, day 2, day 3, day 5, day 7, day 14.
Interventions/Control_4
In patients with acute stage cerebral infarction, patients who had serum LDL cholesterol level at admission of 70 mg / dl or more and had taken statin before hospitalization, will continue only that.
Extract blood collection data of the past record.
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
1. Patients with an LDL cholesterol level of 70 mg / dl or more at hospital blood sampling
2. Patients needing hospitalization due to acute cerebral infarction
Key exclusion criteria
1. Patients who have a history of allergic reactions to the drugs used
2. Patients who are deemed inappropriate by the doctor
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Yoshimura |
Organization
Hyogo college of medicine
Division name
Neurosurgery
Zip code
663-8501
Address
1-1, Mukogawacho, Nishinomiyashi, Hyogo, Japan
TEL
0798-45-6458
s-yoshi@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroto |
| Middle name | |
| Last name | Kakita |
Organization
Hyogo college of medicine
Division name
Neurosurgery
Zip code
663-8501
Address
1-1, Mukogawacho, Nishinomiyashi, Hyogo, Japan
TEL
0798-45-6458
Homepage URL
hkakita@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo college of medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for clinical research and education
Address
1-1, Mukogawacho, Nishinomiyashi, Hyogo, Japan
Tel
0798-45-6111
rinri@hyo-med.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | 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
54
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
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 13 | Day |
Last modified on
| 2019 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035364
| Research Plan | |
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| 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 |
