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

Primary Purpose

Arteriosclerosis, Diabetes Mellitus, Lipid Disorder

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Rosuvastatin 5mg
Rosuvastatin 20mg
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arteriosclerosis focused on measuring Coronary Arteriosclerosis, Carotid Atherosclerotic Plaque, Rosuvastatin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Beijing Tiantan Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

low dose group (5mg)

high dose group (20mg)

Arm Description

low dose Rosuvastatin

high dose Rosuvastatin

Outcomes

Primary Outcome Measures

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 Measures

major adverse cardiovascular events
To 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

Full Information

First Posted
November 26, 2014
Last Updated
July 19, 2016
Sponsor
Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02305862
Brief Title
A High-Resolution Magnetic Resonance Imaging Study to Evaluate the Effect of Rosuvastatin on Carotid Atherosclerotic Plaques
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 Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriosclerosis, Diabetes Mellitus, Lipid Disorder
Keywords
Coronary Arteriosclerosis, Carotid Atherosclerotic Plaque, Rosuvastatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
low dose group (5mg)
Arm Type
Experimental
Arm Description
low dose Rosuvastatin
Arm Title
high dose group (20mg)
Arm Type
Experimental
Arm Description
high dose Rosuvastatin
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin 5mg
Intervention Description
drug intervention
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin 20mg
Intervention Description
drug intervention
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
major adverse cardiovascular events
Time Frame
26 weeks
Title
To evaluate the change in lipid and lipoprotein levels as assessed by percentage change from baseline.
Time Frame
26 weeks
Title
To evaluate the change from baseline in liver function (AST/ALT) at 26 weeks
Time Frame
26 weeks
Title
To evaluate the change from baseline in renal function (serum creatine) at 26 weeks
Time Frame
26 weeks
Title
To evaluate the change from baseline in creatine kinase at 26 weeks
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 Cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Buxing Chen, MD, Ph.D
Phone
861067096572
Email
chbux@126.com
Facility Information:
Facility Name
Beijing Tiantan Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiang Fu, Dr
Phone
861067096562
Email
fuqiang66882000@hotmail.com
First Name & Middle Initial & Last Name & Degree
Buxing Chen, Dr

12. IPD Sharing Statement

Learn more about this trial

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

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