Rosuvastatin Treatment for Intracranial Arterial Stenosis Based on Magnetic Resonance Angiography

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02341794
• Date of registration: 14/01/2015
• Prospective Registration: No
• Primary sponsor: Tokyo Medical University
• Public title: Rosuvastatin Treatment for Intracranial Arterial Stenosis Based on Magnetic Resonance Angiography
• Scientific title: Rosuvastatin Treatment for Intracranial Arterial Stenosis Based on Magnetic Resonance Angiography
• Date of first enrolment: January 2015
• Target sample size: 60
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT02341794
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Japan

Contacts

• Name: Hitoshi Aizawa, MD, PhD
• Affiliation: Tokyo Medical University

• Name: Hitoshi Aizawa, MD, PhD

Key inclusion & exclusion 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



Age minimum: 30 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Intracranial Arterial Diseases

Intervention(s)

Drug: Rosuvastatin

Primary Outcome(s)

Progression of intracranial arterial stenosis after two years [Time Frame: 6 months, 1 year and 2 years]

Secondary Outcome(s)

Cardiovascular events (ischemic stork, cardiac infarction, and other vascular events [Time Frame: 6 months, 1 year and 2 years]

Ischemic stroke or transient ischemic attack [Time Frame: 6 months, 1 year and 2 years]

The change of percentage in LDL-C from baseline [Time Frame: 6 months, 1 year and 2 years]

Ankle brachial index [Time Frame: 6 months, 1 year and 2 years]

Brachial-ankle pulse wave velocity [Time Frame: 6 months, 1 year and 2 years]

Death from any cause [Time Frame: 6 months, 1 year and 2 years]

Intracranial haemorrhage [Time Frame: 6 months, 1 year and 2 years]

Any stroke (ischemic stroke, intracerebral haemorrhage, subarachnoid haemorrhage) [Time Frame: 6 months, 1 year and 2 years]

Adverse events and adverse drug reactions [Time Frame: up to 2 years]

Number of cerebral microbleeds on MRI [Time Frame: 6 months, 1 year and 2 years]

Intracerebral haemorrhage or subarachnoid haemorrhage [Time Frame: 6 months, 1 year and 2 years]

The change in HDL-C level from baseline [Time Frame: 6 months, 1 year and 2 years]

Carotid intima-media thickness [Time Frame: 6 months, 1 year and 2 years]

Secondary ID(s)

2900

Source(s) of Monetary Support

Please refer to primary and secondary sponsors