Intracranial Arterial Diseases Clinical Trial
Official title:
Rosuvastatin Treatment for Intracranial Arterial Stenosis Based on Magnetic Resonance Angiography
The purpose of this study is to investigate the effects of rosuvastatin treatment on degree of intracranial arterial stenosis.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | July 2018 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 30 Years to 80 Years |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Japan | Tokyo Medical University | Shinjuku-ku | Tokyo |
Lead Sponsor | Collaborator |
---|---|
Tokyo Medical University |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression of intracranial arterial stenosis after two years | 6 months, 1 year and 2 years | No | |
Secondary | Any stroke (ischemic stroke, intracerebral haemorrhage, subarachnoid haemorrhage) | 6 months, 1 year and 2 years | No | |
Secondary | Ischemic stroke or transient ischemic attack | 6 months, 1 year and 2 years | No | |
Secondary | Intracerebral haemorrhage or subarachnoid haemorrhage | 6 months, 1 year and 2 years | No | |
Secondary | Death from any cause | 6 months, 1 year and 2 years | No | |
Secondary | Cardiovascular events (ischemic stork, cardiac infarction, and other vascular events | 6 months, 1 year and 2 years | No | |
Secondary | The change of percentage in LDL-C from baseline | 6 months, 1 year and 2 years | No | |
Secondary | The change in HDL-C level from baseline | 6 months, 1 year and 2 years | No | |
Secondary | Intracranial haemorrhage | 6 months, 1 year and 2 years | No | |
Secondary | Number of cerebral microbleeds on MRI | 6 months, 1 year and 2 years | No | |
Secondary | Carotid intima-media thickness | 6 months, 1 year and 2 years | No | |
Secondary | Ankle brachial index | 6 months, 1 year and 2 years | No | |
Secondary | Brachial-ankle pulse wave velocity | 6 months, 1 year and 2 years | No | |
Secondary | Adverse events and adverse drug reactions | up to 2 years | Yes |
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