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
Overview
- Phase
- Not Applicable
- Intervention
- Rosuvastatin 5mg
- Conditions
- Arteriosclerosis
- Sponsor
- Capital Medical University
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- To evaluate whether 26 weeks of treatment with 5/20mg rosuvastatin results in regression of carotid atherosclerotic plaques as measured by CE-MRI
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Investigators
Buxing Chen
Director of department of cardiology
Capital Medical University
Eligibility Criteria
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
Arms & Interventions
low dose group (5mg)
low dose Rosuvastatin
Intervention: Rosuvastatin 5mg
high dose group (20mg)
high dose Rosuvastatin
Intervention: Rosuvastatin 20mg
Outcomes
Primary Outcomes
To evaluate whether 26 weeks of treatment with 5/20mg rosuvastatin results in regression of carotid atherosclerotic plaques as measured by CE-MRI
Time Frame: 26 weeks
Secondary Outcomes
- To evaluate the change from baseline in creatine kinase at 26 weeks(26 weeks)
- major adverse cardiovascular events(26 weeks)
- To evaluate the change from baseline in liver function (AST/ALT) at 26 weeks(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 renal function (serum creatine) at 26 weeks(26 weeks)