Back to resultsRosuvastatin Treatment for Intracranial Arterial Stenosis Based on Magnetic Resonance Angiography
Primary Purpose
Intracranial Arterial Diseases
Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Rosuvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Intracranial Arterial Diseases focused on measuring intracranial arterial disease, dyslipidemia, rosuvastatin
Eligibility Criteria
Inclusion Criteria:
- Male or female patients between 30 and 80 years of age.
- Patients with noncardioembolic ischemic stroke
- Patients with intracranial arterial stenosis ≥50% in supraclinoid internal carotid artery, M1 portion of middle cerebral artery, A1 portion of anterior cerebral artery, P1 portion of posterior cerebral artery, or basilar artery.
- LDL-C level is more than 100 mg/dl (2.6 mmol/L) or under treatment of dyslipidemia
- Patients taking clopidogrel as antiplatelet therapy when providing informed consent
- Patients considered to be able to visit the study site
- Patients who provided written informed consent
Exclusion Criteria:
- Any haemorrhagic stroke or haemorrhagic 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
Sites / Locations
- Tokyo Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rosuvastatin
Arm Description
Outcomes
Primary Outcome Measures
Progression of intracranial arterial stenosis after two years
Secondary Outcome Measures
Any stroke (ischemic stroke, intracerebral haemorrhage, subarachnoid haemorrhage)
Ischemic stroke or transient ischemic attack
Intracerebral haemorrhage or subarachnoid haemorrhage
Death from any cause
Cardiovascular events (ischemic stork, cardiac infarction, and other vascular events
The change of percentage in LDL-C from baseline
The change in HDL-C level from baseline
Intracranial haemorrhage
Number of cerebral microbleeds on MRI
Carotid intima-media thickness
Ankle brachial index
Brachial-ankle pulse wave velocity
Adverse events and adverse drug reactions
Full Information
NCT ID
NCT02341794
First Posted
January 14, 2015
Last Updated
January 17, 2015
Sponsor
Tokyo Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02341794
Brief Title
Rosuvastatin Treatment for Intracranial Arterial Stenosis Based on Magnetic Resonance Angiography
Official Title
Rosuvastatin Treatment for Intracranial Arterial Stenosis Based on Magnetic Resonance Angiography
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
July 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tokyo Medical University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the effects of rosuvastatin treatment on degree of intracranial arterial stenosis.
Detailed Description
The purpose of this study is to investigate the effects of rosuvastatin treatment on degree of intracranial arterial stenosis in two years. Dyslipidemia patients with intracranial arterial stenosis will be enrolled under informed consent in this study. Rosuvastatin (5mg) will be orally administered once daily. Dose of rosuvastatin will be adjusted to control serum LDL-c level under 1.8mmol/L. Primary outcome is the progression of intracranial stenosis on magnetic resonance angiography (MRA) after two years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Arterial Diseases
Keywords
intracranial arterial disease, dyslipidemia, rosuvastatin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rosuvastatin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Intervention Description
Rosuvastatin (5mg) will be orally administrated once daily. Dose of rosuvastatin will be adjusted to control serum LDL-c level under 1.8 mmol/L.
Primary Outcome Measure Information:
Title
Progression of intracranial arterial stenosis after two years
Time Frame
6 months, 1 year and 2 years
Secondary Outcome Measure Information:
Title
Any stroke (ischemic stroke, intracerebral haemorrhage, subarachnoid haemorrhage)
Time Frame
6 months, 1 year and 2 years
Title
Ischemic stroke or transient ischemic attack
Time Frame
6 months, 1 year and 2 years
Title
Intracerebral haemorrhage or subarachnoid haemorrhage
Time Frame
6 months, 1 year and 2 years
Title
Death from any cause
Time Frame
6 months, 1 year and 2 years
Title
Cardiovascular events (ischemic stork, cardiac infarction, and other vascular events
Time Frame
6 months, 1 year and 2 years
Title
The change of percentage in LDL-C from baseline
Time Frame
6 months, 1 year and 2 years
Title
The change in HDL-C level from baseline
Time Frame
6 months, 1 year and 2 years
Title
Intracranial haemorrhage
Time Frame
6 months, 1 year and 2 years
Title
Number of cerebral microbleeds on MRI
Time Frame
6 months, 1 year and 2 years
Title
Carotid intima-media thickness
Time Frame
6 months, 1 year and 2 years
Title
Ankle brachial index
Time Frame
6 months, 1 year and 2 years
Title
Brachial-ankle pulse wave velocity
Time Frame
6 months, 1 year and 2 years
Title
Adverse events and adverse drug reactions
Time Frame
up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients between 30 and 80 years of age.
Patients with noncardioembolic ischemic stroke
Patients with intracranial arterial stenosis ≥50% in supraclinoid internal carotid artery, M1 portion of middle cerebral artery, A1 portion of anterior cerebral artery, P1 portion of posterior cerebral artery, or basilar artery.
LDL-C level is more than 100 mg/dl (2.6 mmol/L) or under treatment of dyslipidemia
Patients taking clopidogrel as antiplatelet therapy when providing informed consent
Patients considered to be able to visit the study site
Patients who provided written informed consent
Exclusion Criteria:
Any haemorrhagic stroke or haemorrhagic 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hitoshi Aizawa, MD, PhD
Phone
+813-3342-6111
Ext
2155
Email
haizawa@tokyo-med.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hitoshi Aizawa, MD, PhD
Organizational Affiliation
Tokyo Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tokyo Medical University
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8402
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daisuke Nishi, M.D., Ph.D.
12. IPD Sharing Statement
Learn more about this trial
Rosuvastatin Treatment for Intracranial Arterial Stenosis Based on Magnetic Resonance Angiography
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