UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016202
Receipt number R000018800
Scientific Title Rosuvastatin for Intracranial Arterial Stenosis on Magnetic Resonace Angiography
Date of disclosure of the study information 2017/01/20
Last modified on 2021/01/17 11:50:53

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Basic information

Public title

Rosuvastatin for Intracranial Arterial Stenosis on Magnetic Resonace Angiography

Acronym

Rosuvastatin for Intracranial Arterial Stenosis on Magnetic Resonace Angiography

Scientific Title

Rosuvastatin for Intracranial Arterial Stenosis on Magnetic Resonace Angiography

Scientific Title:Acronym

Rosuvastatin for Intracranial Arterial Stenosis on Magnetic Resonace Angiography

Region

Japan


Condition

Condition

Intracranial Arterial Stenosis

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to investigate the effects of rosuvastatin treatment on degree of intracranial arterial stenosis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Progression of intracranial stenosis after two years

Key secondary outcomes

Any stroke [ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage]
Ischemic stroke or transient ischemic attack (TIA)
Intracerebral hemorrhage or subarachnoid hemorrhage
Death from any cause
All vascular events (stroke, myocardial infarction, or other vascular events)
The change in LDL-c level from baseline
The change in HDL-c level from baseline
Number of cerebral microbleeds on MRI
Carotid intima-media thickness
Ankle brachial index
Brachial-ankle pulse wave velocity
Adverse events and adverse drug reactions


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Rosuvastatin (5mg) will be orally administered once daily. Dose of rosuvastatin will be adjusted to control serum LDL-c level under 70 mg/dl (1.8mmol/L).
Clopidogrel (50mg or 75mg) will be orally administrated once daily.

Interventions/Control_2


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

30 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients aged 30 to 80 years old when providing informed consent
Patients with non-cardioembolic ischemic stroke
Patients with intracranial arterial stenosis 50% or more than 50% on MRA (supra-clinoidal internal carotid artery, M1 portion of middle cerebral artery, A1 portion of anterior cerebral artery, P1 portion of posterior cerebral artery, or basilar artery)
Patients with dyslipidemia (LDL-c mg/dL; 2.6 mmol/L) or under the treatment of dyslipidemia
Patients taking clopidogrel as anti-platelet therapy when providing informed consent
Patients considered to be able to visit the study site
Patients who provided written informed consent

Key exclusion criteria

Any hemorrhagic stroke or hemorrhagic infarction
Familial hypercholesterolemia
Patients with uncontrolled angina pectoris or congestive heart failure
Patients with severe liver or renal dysfunction
Patients with a malignant tumor requiring treatment
Patients with uncontrolled diabetes mellitus
Patients with secondary dyslipidemia (due to corticosteroid etc)
Patients with a history of myopathy
Patients considered by the investigator to be unsuitable for participating in this study

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Hitoshi
Middle name
Last name Aizawa

Organization

Tokyo Medical University

Division name

Department of Neurology

Zip code

1600023

Address

6-7-1, Nishi-shinjuku, Shinjuku-ku, tokyo Japan

TEL

+81-3-3342-6111

Email

haizawa@tokyo-med.ac.jp


Public contact

Name of contact person

1st name Hitoshi
Middle name
Last name Aizawa

Organization

Tokyo Medical University

Division name

Department of Neurology

Zip code

1600023

Address

6-7-1, Nishi-shinjuku, Shinjuku-ku, tokyo Japan

TEL

+81-3-3342-6111

Homepage URL


Email

haizawa@tokyo-med.ac.jp


Sponsor or person

Institute

Department of Neurology. Tokyo Medical University

Institute

Department

Personal name



Funding Source

Organization

Tokyo Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tokyo Medical University

Address

Nishi-shinjuku 6-7-1, Shinjuku-ku, Tokyo, 160-0023, Japan

Tel

+81-3-3342-6111

Email

d-somu@tokyo-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

東京医科大学病院(東京都) Tokyo Medical University Hospital (Tokyo)


Other administrative information

Date of disclosure of the study information

2017 Year 01 Month 20 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


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

2016 Year 12 Month 01 Day

Date of IRB

2014 Year 12 Month 01 Day

Anticipated trial start date

2017 Year 01 Month 20 Day

Last follow-up date

2021 Year 04 Month 01 Day

Date of closure to data entry

2021 Year 04 Month 01 Day

Date trial data considered complete

2021 Year 04 Month 01 Day

Date analysis concluded

2021 Year 06 Month 30 Day


Other

Other related information



Management information

Registered date

2015 Year 01 Month 13 Day

Last modified on

2021 Year 01 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018800


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name