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The purpose of this study is to investigate the effects of rosuvastatin treatment on degree of intracranial arterial stenosis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression of intracranial arterial stenosis after two years | 6 months, 1 year and 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Any stroke (ischemic stroke, intracerebral haemorrhage, subarachnoid haemorrhage) | 6 months, 1 year and 2 years | |
| Ischemic stroke or transient ischemic attack | 6 months, 1 year and 2 years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hitoshi Aizawa, MD, PhD | Contact | +813-3342-6111 | 2155 | haizawa@tokyo-med.ac.jp |
| Name | Affiliation | Role |
|---|---|---|
| Hitoshi Aizawa, MD, PhD | Tokyo Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo Medical University | Recruiting | Shinjuku-ku | Tokyo | 160-8402 | Japan |
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| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Intracerebral haemorrhage or subarachnoid haemorrhage |
| 6 months, 1 year and 2 years |
| Death from any cause | 6 months, 1 year and 2 years |
| Cardiovascular events (ischemic stork, cardiac infarction, and other vascular events | 6 months, 1 year and 2 years |
| The change of percentage in LDL-C from baseline | 6 months, 1 year and 2 years |
| The change in HDL-C level from baseline | 6 months, 1 year and 2 years |
| Intracranial haemorrhage | 6 months, 1 year and 2 years |
| Number of cerebral microbleeds on MRI | 6 months, 1 year and 2 years |
| Carotid intima-media thickness | 6 months, 1 year and 2 years |
| Ankle brachial index | 6 months, 1 year and 2 years |
| Brachial-ankle pulse wave velocity | 6 months, 1 year and 2 years |
| Adverse events and adverse drug reactions | up to 2 years |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |