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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02305862

Enrollment

150

Registered

2014-12-03

Start date

2013-01-31

Completion date

2017-07-31

Last updated

2016-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arteriosclerosis, Diabetes Mellitus, Lipid Disorder

Keywords

Coronary Arteriosclerosis, Carotid Atherosclerotic Plaque, Rosuvastatin

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.

Interventions

DRUGRosuvastatin 5mg

drug intervention

DRUGRosuvastatin 20mg

drug intervention

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	Time frame
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 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
To evaluate the change in lipid and lipoprotein levels as assessed by percentage change from baseline.	26 weeks

Countries

China

Contacts

Primary ContactBuxing Chen, MD, Ph.D

chbux@126.com861067096572

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026