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
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 26, 2014
CompletedFirst Posted
Study publicly available on registry
December 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedJuly 21, 2016
July 1, 2016
3.9 years
November 26, 2014
July 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
major adverse cardiovascular events
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 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
Study Arms (2)
low dose group (5mg)
EXPERIMENTALlow dose Rosuvastatin
high dose group (20mg)
EXPERIMENTALhigh dose Rosuvastatin
Interventions
Eligibility Criteria
You may qualify if:
- Patients with coronary artery disease or carotid atherosclerotic plaque or hyperlipideimia or old myocardial infarction
You may not qualify if:
- Planning coronary stenting
- Heart failure
- Uncontrolled hypertension（≥200/110mmHg)
- Uncontrolled diabetes mellitus (HbA1C≥9.5%)
- Hepatic insufficiency
- Renal dysfunction
- Cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Tiantan Hospital, Capital Medical University
Beijing, 100050, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of department of cardiology
Study Record Dates
First Submitted
November 26, 2014
First Posted
December 3, 2014
Study Start
January 1, 2013
Primary Completion
December 1, 2016
Study Completion
July 1, 2017
Last Updated
July 21, 2016
Record last verified: 2016-07