UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	AdminiStration of Statin On acute ischemic stRoke patienT Trial
Title of the study (Brief title)	ASSORT Trial
Region	Japan

Condition
Condition	Cerebral infarction (except for TIA or cardioembolic) with hypercholesterolemia
Classification by specialty	Neurology Neurosurgery Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	It is much more important in Japan than Western to improve the prognosis after stroke because the prevalence and mortality rate of stroke in Japan is about 3-4 times as those of acute myocardial infarction. We will study whether immediate statin treatment after the onset of stroke is beneficial on the neurological protection since most of previous studies with statins just showed the preventive effects from onset of primary or recurrent cerebral infarction.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase IV

Assessment
Primary outcomes	Degree of disability or dependence in the daily routine activities [Time Frame: 90 days from admission] [Designated as safety issue: No] Degree of disability or dependence in the daily routine activities: modified Rankin Scale (mRS) score
Key secondary outcomes	Quantitative evaluation of stroke-related neurologic deficit [Time Frame: 7 days from admission] [Designated as safety issue: No] The clinical stroke assessment to evaluate neurological status: The National Institutes of Health Stroke Scale (NIHSS) Changes in lipid profile [Time Frame: At admission and earlier day either 21th day from admission or discharge] [Designated as safety issue: No ] LDL-C value is calculated by Friedewald formula. Occurrence of major adverse cardiac and cerebrovascular event [ Time Frame: During admission and 90 days from initial admission ] [ Designated as safety issue: Yes ] Major adverse cardiac and cerebrovascular events include acute myocardial infarction, unstable angina, new-onset cerebral infarction, non-traumatic intracerebral hemorrhage, subarachnoidal hemorrhage and large vessel disease or peripheral artery disease to be treated. Changes in laboratory test values and occurrence of pneumonia[ Time Frame: At admission and earlier day either 21th day from admission or discharge ] [ Designated as safety issue: Yes ] Safety [ Time Frame: During initial admission and 90days from admission ] [ Designated as safety issue: Yes ]

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Experimental: strong statin treatment Participants received strong statin tablet orally once daily for 90days, which is initiated within 24 hours after admission Atorvastatin 20 mg or Pitavasttain 4 mg or Rosuvastatin 5 mg
Interventions/Control_2	Comparator: strong statin treatment Participants received strong statin tablet orally once daily for 11 weeks, which is initiated from 7 days after admission Atorvastatin 20 mg or Pitavasttain 4 mg or Rosuvastatin 5 mg
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	Subjects who give us the consent of participation with the document by their free will or by substitutes when subjects cannot do it by themselves Inpatients At least 20 years of age Acute ischemic stroke subjects within 24 hours after onset Subjects whose diagnosis are confirmed as cerebral infarction except for TIA by MRI at transport to hospital. Subjects with hypercholesterolemia (serum LDL-C value of 100 mg / dL or more, or diagnosed as hypercholesterolemia before) Subjects who can orally take drugs in within 24 hours after admission Subjects who can be treated according to this study procedures during study period
Key exclusion criteria	Subjects with history of hypersensitivity to the agent of this study Subjects with deterioration in liver function attributable to acute hepatitis, acute exacerbation of chronic hepatitis, cirrhosis, liver cancer, jaundice, and so on, or with suspected biliary obstruction Subjects who are administered cyclosporine or telaprevir Subjects with moderate or severe renal impairment (SCr>=2.5mg/dL or eGFR<30mg/dL) Subjects who received a diagnosis of acute coronary syndrome within 6 months Subjects with valvular disease, atrial fibrillation, atrial thrombosis Subjects with familial hypercholesterolemia Subjects who are pregnant or may be Subjects whose NIHSS scores are 20 or higher on admission, or mRS score was more than 2 before the onset Subjects that doctors deemed inappropriate by other reasons
Target sample size	270

Research contact person
Name of lead principal investigator	Yoshimura Shinichi
Organization	Hyogo college of medicine
Division name	Neurosurgery
Address	Japan, Hyogo Nishinomiya, Hyogo, Japan
TEL	0798-45-6458
Email	ccred15001r-h@hyo-med.ac.jp

Public contact
Name of contact person	Uchida Kazutaka
Organization	Hyogo college of medicine
Division name	Neurosurgery
Address	Japan, Hyogo Nishinomiya, Hyogo, Japan
TEL	0798-45-6458
Homepage URL	http://assort-trial.com
Email	ccred15001r-h@hyo-med.ac.jp

Sponsor
Institute	Hyogo college of medicine
Institute
Department

Funding Source
Organization	Hyogo College Of Medicine Shionogi & Co., Ltd, Osaka, Japan
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1	ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	兵庫医科大学病院 脳神経外科 (兵庫県) 医療法人 榮昌会 吉田病院 脳神経外科 (兵庫県) 医療法人社団 敬誠会 合志病院 脳神経外科 (兵庫県) 三田市民病院 脳神経外科 (兵庫県) 社会医療法人愛仁会　千船病院 脳神経外科 (大阪府) 医療法人 清仁会 シミズ病院 脳神経外科 (京都府) 社会医療法人神鋼記念会　神鋼病院　脳神経外科　(兵庫県) 特定医療法人中央会　尼崎中央病院　脳神経外科 (兵庫県) 神戸徳州会病院 (兵庫県) 医療法人財団報徳会　西湘病院　(神奈川県) 一般財団法人黎明郷弘前脳卒中･リハビリテーションセンター　（青森県） 国立病院機構 熊本医療センター （熊本県） 熊本赤十字病院　（熊本県）

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 07 Day
Anticipated trial start date	2015 Year 09 Month 07 Day
Last follow-up date	2016 Year 09 Month 30 Day
Date of closure to data entry	2016 Year 11 Month 30 Day
Date trial data considered complete	2016 Year 12 Month 01 Day
Date analysis concluded	2016 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 08 Month 12 Day
Last modified on	2018 Year 06 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021032