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
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
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
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
