Rosuvastatin Treatment for Intracranial Arterial Stenosis Based on Magnetic Resonance Angiography

Not Applicable

• Conditions: Intracranial Arterial Diseases
• Interventions: Drug: Rosuvastatin

• Registration Number: NCT02341794
• Lead Sponsor: Tokyo Medical University

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.

Study Timeline

• Status Verified: 2015-01
• Study Start: 2015-01
• Study First Submitted: 2015-01-14
• Study First Submitted QC: 2015-01-16
• Last Update Submitted: 2015-01-17
• Study First Posted: 2015-01-19
• Last Update Posted: 2015-01-21
• Primary Completion: 2017-12
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rosuvastatin	Rosuvastatin	-

Primary Outcome Measures

Name	Time	Method
Progression of intracranial arterial stenosis after two years	6 months, 1 year and 2 years

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Tokyo Medical University; 🇯🇵 Shinjuku-ku, Tokyo, Japan