NCT00997880

Statin and Atheroma Vulnerability Evaluation

Effect of High-Dose and Low-Dose Statin for Coronary Plaque Modification

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 312 (actual)
• Sponsor: Seung-Jung Park · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effect of statin therapy on the modification of atherosclerotic plaque composition and vulnerability in non-intervened coronary arteries with mild to moderate stenosis using VH-IVUS and OCT.

Detailed description

At present, there is no proven drug or modality to stabilize the vulnerable plaques. A number of drugs that are beneficial for patients with coronary disease may act in part by improving the stability of plaques that are vulnerable for future rupture. Especially, Lipid-lowering therapy, particularly with statins, can stabilize vulnerable plaques or those that have already ruptured by improving endothelial function and reducing thrombogenicity, platelet aggregation, and possibly inflammation. As the atherosclerotic disease has progressed, there is an increase of the atherosclerotic plaque amounts. However, the changes of specific plaque compositions within the atherosclerotic lesions have not been sufficiently evaluated. Previous pathologic findings reported that there was a significant relation between the plaque size and necrotic core size.Conventional grey-scale intravascular ultrasound (IVUS) has significant limitations in accurately assessing atheromatous plaque composition. These limitations have been partially addressed by radiofrequency signal processing with spectral analysis of the back-scattered ultrasound signals. Using this technology, Virtual Histology (VH) IVUS is capable of characterizing plaque as calcified (white), fibrotic (dark-green), fibrofatty (yellow-green), and necrotic core (red). In addition, optical coherence tomography (OCT) is a light-based imaging modality that can be used in biological systems to study tissues in vivo with near-histologic, ultrahigh resolution. The rationale for intravascular application of OCT is its potential for in vivo visualizations of the coronary artery microstructure. This unique image resolution of OCT offers the potential to detect key features of vulnerable plaque in vivo. Beyond the inherent limitations of angioscopy and intravascular ultrasound, OCT might offer a much higher sensitivity in the detection of necrotic/lipid cores within coronary atheromas. Therefore, plaque characterization using VH-IVUS and OCT may provide detailed morphologic insights of plaque vulnerability. We hypothesized that statin would provide benefits to stabilize coronary plaque composition by LDL-reduction and/or a pleiotropic effect. We also hypothesized that high-dose statin would be more beneficial in reducing the vulnerable plaque and stabilizing the vulnerable plaque composition than low-dose statin.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Rosuvastatin calcium 40mg	Rosuvastatin calcium 40mg
DRUG	Rosuvastatin calcium10mg	Rosuvastatin 10mg

Timeline

• Start date: 2010-04-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2009-10-19
• Last updated: 2014-12-25

Locations

1 site across 1 country: South Korea