Effects of lipid lowering by atorvastatin on carotid atherosclerotic plaque (ACAP) study: a randomized trial for analysis of qualitative change in carotid atherosclerrotic plaque with IB echo and Black Blood MRI

UMIN ID: UMIN000001114

Registered date:01/05/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Carotid artery stenosis
• Date of first enrollment: 2006/06/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Atorvastatin
Diet

Outcome(s)

• Primary Outcome: The property change in carotid artery plaque after three and six months using IB echo and Black Blood MRI.
• Secondary Outcome: 1) The change of the serum lipid metabolism in six months: Serum total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides 2) The change of the inflammatory marker in six months: serum high sensitivity CRP 3) Ischemic attack in the territory of the internal carotid artery on the ipsilateral side

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Patients with a history of adverse effects or allergy to atorvastatin 2) Patients with a history of angina or miocardial infarction 3) Patients parformed carotid endartelectomy or carotid artery stenting before the entry of the study 4) Patients who are pregnant, possibly pregnant, or lactating 5) Patients judged inappropriate for this study by a physician

Related Information

• Primary Sponsor: Gifu University Graduate School of Medicine Department of Neurosurgery
• Source(s) of Monetary Support: None