Intracranial Arterial Diseases
Conditions
Keywords
intracranial arterial disease, dyslipidemia, rosuvastatin
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.
Interventions
DRUGRosuvastatin
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.
Sponsors
Tokyo Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female patients between 30 and 80 years of age. 2. Patients with noncardioembolic ischemic stroke 3. 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. 4. LDL-C level is more than 100 mg/dl (2.6 mmol/L) or under treatment of dyslipidemia 5. Patients taking clopidogrel as antiplatelet therapy when providing informed consent 6. Patients considered to be able to visit the study site 7. Patients who provided written informed consent
Exclusion criteria
1. Any haemorrhagic stroke or haemorrhagic infarction 2. Familial hypercholesterolemia 3. Patients with uncontrolled angina pectoris or congestive heart failure 4. Patients with severe liver or renal dysfunction 5. Patients with a malignant tumor requiring treatment 6. Patients with uncontrolled diabetes mellitus 7. Patients with secondary dyslipidemia (due to corticosteroid etc) 8. Patients with a history of myopathy 9. Patients considered by the investigator to be unsuitable for participating in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression of intracranial arterial stenosis after two years | 6 months, 1 year and 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Ischemic stroke or transient ischemic attack | 6 months, 1 year and 2 years |
| 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 |
| Any stroke (ischemic stroke, intracerebral haemorrhage, subarachnoid 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 |
| Intracranial haemorrhage | 6 months, 1 year and 2 years |
Countries
Japan
Contacts
Primary ContactHitoshi Aizawa, MD, PhD
Outcome results
None listed