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Evaluation of Statin-induced Lipid-rich Plaque Progression by Optical Coherence Tomography (OCT) Combined With Intravascular Ultrasound (IVUS)

NCT01023607 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2013-09-11

No results posted yet for this study

Summary

Many trials suggested that lipid lowering therapy could significantly reduce cardiovascular events. Enhancing stability of vulnerable plaque is probably the main reason by which statins reduce adverse coronary events. The size of lipid core and the fibrous cap thickness (FCT) are the major determinants of plaque vulnerability. So, it is very important to accurately evaluate changes in plaque after stains therapy.

Previous reports suggested that intensive lipid lowering therapy provide more significantly clinical benefit compared with moderate lipid lowering therapy.Such benefit may contribute to the changes in following parameters: FCT, lipid arc(quadrants), TCFA, macrophage, plaque disruption, and thrombus measured by OCT, and plaque burden and remodeling index by IVUS.

Current intravascular imaging modalities, such as optical coherence tomography (OCT) and intravascular ultrasound (IVUS) can provide in vivo quantitative and qualitative information of coronary plaques. However, there were few studies aimed at monitoring the progression of coronary plaques in patients receiving statin therapy by OCT combined with IVUS.

Therefore, the study we designed were to compare the effect of the rosuvastatin 10mg, atorvastatin 20mg and atorvastatin 60mg treatment on the changes in FCT and lipid core arc by OCT and plaque burden by IVUS of coronary atherosclerotic plaques.

Conditions

Interventions

DRUG

Atorvastatin

Atorvastatin 20mg/day

DRUG

Atorvastatin

Atorvastatin, 60mg/day

DRUG

Rosuvastatin

Rosuvastatin,10mg/day

Sponsors & Collaborators

  • Harbin Medical University

    lead OTHER

Principal Investigators

  • Bo Yu, MD,PhD · The Second Affiliated Hospital of Harbin Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01023607 on ClinicalTrials.gov