CClinicalTrials.gg
Status unknownNCT02305862Updated Jul 21, 2016

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

An interventional study of Rosuvastatin 5mg and Rosuvastatin 20mg in Arteriosclerosis, Diabetes Mellitus and Lipid Disorder, sponsored by Capital Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-07-21.

Sponsored by Capital Medical University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Arteriosclerosis
  • Diabetes Mellitus
  • Lipid Disorder

Keywords

  • Coronary Arteriosclerosis
  • Carotid Atherosclerotic Plaque
  • Rosuvastatin
03

In context

Arteriosclerosis

317 studies on the registry are indexed under Arteriosclerosis; 33 are open to participants now.

This study's planned enrollment of 150 is close to the median of 144 across 182 interventional studies indexed under Arteriosclerosis.

Browse Arteriosclerosis studies →

Lead sponsor

Capital Medical University is the lead sponsor of 283 studies on the registry; 92 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

-Patients with coronary artery disease or carotid atherosclerotic plaque or hyperlipideimia or old myocardial infarction

Exclusion criteria

Exclusion Criteria:

  • Planning coronary stenting
  • Heart failure
  • Uncontrolled hypertension(≥200/110mmHg)
  • Uncontrolled diabetes mellitus (HbA1C≥9.5%)
  • Hepatic insufficiency
  • Renal dysfunction
  • Cancer
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    low dose group (5mg)

    low dose Rosuvastatin

    Drug: Rosuvastatin 5mg

  • Experimental
    high dose group (20mg)

    high dose Rosuvastatin

    Drug: Rosuvastatin 20mg

Interventions

  • DrugRosuvastatin 5mg

    drug intervention

  • DrugRosuvastatin 20mg

    drug intervention

06

What researchers measure

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

    Time frame: 26 weeks

Secondary outcomes

  1. major adverse cardiovascular events

    Time frame: 26 weeks

  2. To evaluate the change in lipid and lipoprotein levels as assessed by percentage change from baseline.

    Time frame: 26 weeks

  3. To evaluate the change from baseline in liver function (AST/ALT) at 26 weeks

    Time frame: 26 weeks

  4. To evaluate the change from baseline in renal function (serum creatine) at 26 weeks

    Time frame: 26 weeks

  5. To evaluate the change from baseline in creatine kinase at 26 weeks

    Time frame: 26 weeks

07

Study locations

1 of 1 sites recruiting
  • Beijing Tiantan Hospital, Capital Medical University
    Beijing, 100050, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02305862
Lead sponsor
Capital Medical University
Responsible party
Buxing Chen (Director of department of cardiology, Capital Medical University) — Principal investigator
First posted
Dec 3, 2014
Start date
Jan 2013
Primary completion
Dec 2016 (estimated)
Completion
Jul 2017 (estimated)
Last update
Jul 21, 2016

Study contacts

Buxing Chen, MD, Ph.D
Contact
chbux@126.com
861067096572

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion