UMIN-CTR Clinical Trial

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

Cerebral infarction (except for TIA or cardioembolic) with hypercholesterolemia

Classification by specialty

Neurology	Neurosurgery	Adult

Classification by malignancy

Others

Genomic information

NO

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

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 ]

Study type

Interventional

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

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

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

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

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

Institute

Hyogo college of medicine

Institute

Department

Personal name

Organization

Hyogo College Of Medicine
Shionogi & Co., Ltd, Osaka, Japan

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

JAPAN

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

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）

Date of disclosure of the study information

2015

Year

08

Month

15

Day

URL releasing protocol

Publication of results

Published

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

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 related information

Registered date

2015

Year

08

Month

12

Day

Last modified on

2018

Year

06

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021032