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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016202
Receipt No. 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 2017/01/11

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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
Middle name
Last name Hitoshi Aizawa
Organization Tokyo Medical University
Division name Department of Neurology
Zip code
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
Middle name
Last name Hitoshi Aizawa
Organization Tokyo Medical University
Division name Department of Neurology
Zip code
Address 6-7-1, Nishi-shinjuku, Shinjuku-ku, tokyo Japan
TEL +81-3-3342-6111
Homepage URL
Email haizawa@tokyo-med.ac.jp

Sponsor
Institute Department of Neurology. Tokyo Medical University
Institute
Department

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
Address
Tel
Email

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 Enrolling by invitation
Date of protocol fixation
2016 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 01 Month 13 Day
Last modified on
2017 Year 01 Month 11 Day


Link to view the page
URL(English) https://upload.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


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