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.

Study Overview

• Status: Unknown
• Conditions: Intracranial Arterial Diseases
• Intervention / Treatment: Drug: Rosuvastatin

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hitoshi Aizawa, MD, PhD; Phone Number: 2155 +813-3342-6111; Email: haizawa@tokyo-med.ac.jp

Study Locations

• Japan
  • Tokyo
    • Shinjuku-ku, Tokyo, Japan, 160-8402
      • Recruiting
      • Tokyo Medical University
      • Principal Investigator: Daisuke Nishi, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rosuvastatin	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression of intracranial arterial stenosis after two years	6 months, 1 year and 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Tokyo Medical University
• Investigators: Principal Investigator: Hitoshi Aizawa, MD, PhD, Tokyo Medical University

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: January 14, 2015
• First Submitted That Met QC Criteria: January 16, 2015
• First Posted (Estimate): January 19, 2015

Study Record Updates

• Last Update Posted (Estimate): January 21, 2015
• Last Update Submitted That Met QC Criteria: January 17, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: rosuvastatin; dyslipidemia; intracranial arterial disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium
• Other Study ID Numbers: 2900