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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018657
Receipt No. R000021032
Scientific Title AdminiStration of Statin On acute ischemic stRoke patienT Trial
Date of disclosure of the study information 2015/08/15
Last modified on 2018/06/10

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Basic information
Public title AdminiStration of Statin On acute ischemic stRoke patienT Trial
Acronym ASSORT Trial
Scientific Title AdminiStration of Statin On acute ischemic stRoke patienT Trial
Scientific Title:Acronym 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
1st name
Middle name
Last name Yoshimura Shinichi
Organization Hyogo college of medicine
Division name Neurosurgery
Zip code
Address Japan, Hyogo Nishinomiya, Hyogo, Japan
TEL 0798-45-6458
Email ccred15001r-h@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Uchida Kazutaka
Organization Hyogo college of medicine
Division name Neurosurgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2015 Year 07 Month 07 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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