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

Not Applicable

• Conditions: Arteriosclerosis; Lipid Disorder; Diabetes Mellitus
• Interventions: Drug: Rosuvastatin 5mg; Drug: Rosuvastatin 20mg

• Registration Number: NCT02305862
• Lead Sponsor: Capital Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-11-26
• Study First Submitted QC: 2014-12-02
• Study First Posted: 2014-12-03
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-19
• Last Update Posted: 2016-07-21
• Primary Completion: 2016-12
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low dose group (5mg)	Rosuvastatin 5mg	low dose Rosuvastatin
high dose group (20mg)	Rosuvastatin 20mg	high dose Rosuvastatin

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, China