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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02305862
• Other study ID #: AMARIROCAP
• Status: Recruiting
• Phase: N/A
• First received: November 26, 2014
• Last updated: July 19, 2016
• Start date: January 2013
• Est. completion date: July 2017

Study information

• Verified date: July 2016
• Source: Capital Medical University
• Contact: Buxing Chen, MD, Ph.D
• Phone: 861067096572
• Email: chbux[@]126.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriosclerosis
• Diabetes Mellitus
• Lipid Disorder
• Lipid Metabolism Disorders
• Plaque, Atherosclerotic

Intervention

Drug:
• Rosuvastatin 5mg
drug intervention
• Rosuvastatin 20mg
drug intervention

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	major adverse cardiovascular events		26 weeks	No
Secondary	To evaluate the change in lipid and lipoprotein levels as assessed by percentage change from baseline.		26 weeks	No
Secondary	To evaluate the change from baseline in liver function (AST/ALT) at 26 weeks		26 weeks	Yes
Secondary	To evaluate the change from baseline in renal function (serum creatine) at 26 weeks		26 weeks	Yes
Secondary	To evaluate the change from baseline in creatine kinase at 26 weeks		26 weeks	Yes