Rosuvastatin Treatment for Intracranial Arterial Stenosis Based on Magnetic Resonance Angiography

NCT ID: NCT02341794

Last Updated: 2015-01-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2018-07-31

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.

Conditions

Intracranial Arterial Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rosuvastatin

Group Type: EXPERIMENTAL

Rosuvastatin

Intervention Type: DRUG

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.

Interventions

Rosuvastatin

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tokyo Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hitoshi Aizawa, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tokyo Medical University

Locations

Tokyo Medical University

Shinjuku-ku, Tokyo, Japan

Site Status: RECRUITING

Countries

Japan

Central Contacts

Hitoshi Aizawa, MD, PhD

Role: CONTACT

haizawa@tokyo-med.ac.jp

+813-3342-6111 ext. 2155

Other Identifiers

2900

Identifier Type: -

Identifier Source: org_study_id