A High-Resolution Magnetic Resonance Imaging Study to Evaluate the Effect of Rosuvastatin on Carotid Atherosclerotic Plaques

Study Overview
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Brief Summary
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The aim of this study is to assess whether high intensive statin therapy could regress carotid atherosclerotic plaques as determined by High-Resolution Contrast Enhanced Magnetic Resonance imaging (CE-MRI). Enrolled patients have a baseline CE-MRI examination for screening carotid atherosclerotic plaques and are randomized to either low dose of Rosuvastatin (5mg) group or high dose of Rosuvastatin (20mg) group. After 26 weeks, all patients received CE-MRI examination again and each pair of baseline and follow-up CE-MRI assessments was analyzed in a blinded fashion. Moreover, lipid level and major adverse cardiovascular events are also evaluated during follow-up.

Official Title
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An Open-label, Single-centre Randomized Study Evaluating the Effect of Treatment With Rosuvastatin 5/20mg on Atherosclerotic Disease as Measured by High-Resolution Contrast Enhanced Magnetic Resonance Imaging in Patients With Coronary Artery Disease and Hyperlipideimia

Conditions
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Arteriosclerosis, Diabetes Mellitus, Lipid Disorder

Intervention / Treatment
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* Drug: Rosuvastatin 5mg
* Drug: Rosuvastatin 20mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Patients with coronary artery disease or carotid atherosclerotic plaque or hyperlipideimia or old myocardial infarction Exclusion Criteria: Planning coronary stenting Heart failure Uncontrolled hypertension（≥200/110mmHg) Uncontrolled diabetes mellitus (HbA1C≥9.5%) Hepatic insufficiency Renal dysfunction Cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low dose group (5mg)<br>low dose Rosuvastatin | Drug: Rosuvastatin 5mg<br>* drug intervention<br>|
| Experimental: high dose group (20mg)<br>high dose Rosuvastatin | Drug: Rosuvastatin 20mg<br>* drug intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate whether 26 weeks of treatment with 5/20mg rosuvastatin results in regression of carotid atherosclerotic plaques as measured by CE-MRI |  | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major adverse cardiovascular events |  | 26 weeks | 
| To evaluate the change in lipid and lipoprotein levels as assessed by percentage change from baseline. |  | 26 weeks | 
| To evaluate the change from baseline in liver function (AST/ALT) at 26 weeks |  | 26 weeks | 
| To evaluate the change from baseline in renal function (serum creatine) at 26 weeks |  | 26 weeks | 
| To evaluate the change from baseline in creatine kinase at 26 weeks |  | 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Arteriosclerosis, Carotid Atherosclerotic Plaque, Rosuvastatin