Clinical trial NCT02341794: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Intracranial Arterial Diseases
Keywords: intracranial arterial disease
dyslipidemia
rosuvastatin
Lead sponsor: Tokyo Medical University
Sponsor class: OTHER
First posted: 2015-01-19
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression of intracranial arterial stenosis after two years
timeFrame: 6 months, 1 year and 2 years
Secondary outcomes:
measure: Any stroke (ischemic stroke, intracerebral haemorrhage, subarachnoid haemorrhage)
timeFrame: 6 months, 1 year and 2 years
measure: Ischemic stroke or transient ischemic attack
timeFrame: 6 months, 1 year and 2 years
measure: Intracerebral haemorrhage or subarachnoid haemorrhage
timeFrame: 6 months, 1 year and 2 years
measure: Death from any cause
timeFrame: 6 months, 1 year and 2 years
measure: Cardiovascular events (ischemic stork, cardiac infarction, and other vascular events
timeFrame: 6 months, 1 year and 2 years
measure: The change of percentage in LDL-C from baseline
timeFrame: 6 months, 1 year and 2 years
measure: The change in HDL-C level from baseline
timeFrame: 6 months, 1 year and 2 years
measure: Intracranial haemorrhage
timeFrame: 6 months, 1 year and 2 years
measure: Number of cerebral microbleeds on MRI
timeFrame: 6 months, 1 year and 2 years
measure: Carotid intima-media thickness
timeFrame: 6 months, 1 year and 2 years
measure: Ankle brachial index
timeFrame: 6 months, 1 year and 2 years
measure: Brachial-ankle pulse wave velocity
timeFrame: 6 months, 1 year and 2 years
measure: Adverse events and adverse drug reactions
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University
state: Tokyo
Study officials:
affiliation: Tokyo Medical University
name: Hitoshi Aizawa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: