A High-Resolution Magnetic Resonance Imaging Study to Evaluate the Effect of Rosuvastatin on Carotid Atherosclerotic Plaques
Information source: Capital Medical University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Arteriosclerosis; Diabetes Mellitus; Lipid Disorder
Intervention: Rosuvastatin 5mg (Drug); Rosuvastatin 20mg (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Capital Medical University Overall contact: Buxing Chen, MD, Ph.D, Phone: 861067096572, Email: chbux@126.com
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To evaluate whether 26 weeks of treatment with 5/20mg rosuvastatin results in regression of carotid atherosclerotic plaques as measured by CE-MRI
Secondary outcome: major adverse cardiovascular eventsTo evaluate the change in lipid and lipoprotein levels as assessed by percentage change from baseline. To evaluate the change from baseline in liver function (AST/ALT) at 26 weeks To evaluate the change from baseline in renal function (serum creatine) at 26 weeks To evaluate the change from baseline in creatine kinase at 26 weeks
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
- Cancer
Locations and Contacts
Buxing Chen, MD, Ph.D, Phone: 861067096572, Email: chbux@126.com
Beijing Tiantan Hospital, Capital Medical University, Beijing 100050, China; Recruiting Qiang Fu, Dr, Phone: 861067096562, Email: fuqiang66882000@hotmail.com Buxing Chen, Dr, Principal Investigator
Additional Information
Starting date: January 2013
Last updated: July 27, 2015
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