UMIN-CTR Clinical Trial

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
Last 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
Email	s-yoshi@hyo-med.ac.jp

Public contact
1st 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
Email	hkakita@hyo-med.ac.jp

Sponsor
Institute	Hyogo college of medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035364