Evaluation of Statin-induced Lipid-rich Plaque Progression by Optical Coherence Tomography (OCT) Combined With Intravascular Ultrasound (IVUS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01023607|
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : September 11, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Hyperlipidemia||Drug: Atorvastatin Drug: Rosuvastatin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Evaluation of Statin-induced Lipid-rich Plaque Progression by Optical Coherence Tomography (OCT)Combined With Intravascular Ultrasound (IVUS)|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
Active Comparator: Group A:
Experimental: Group B:
Active Comparator: Group C:
- To compare the effects of atorvastatin 20mg and atorvastatin 60mg on the changes of FCT assessed by OCT and plaque burden by IVUS. [ Time Frame: 12 months after enrollment ]
- To investigate the changes of FCT assessed by OCT and plaque burden by IVUS in comparisons of atorvastatin 60 mg vs rosuvastatin 10 mg, and atorvastatin 20 mg vs rosuvastatin 10 mg. [ Time Frame: 12 months ]
- To investigate the changes of remodeling index assessed by IVUS in comparisons of atorvastatin 60 mg vs atorvastatin 20 mg,atorvastatin 60 mg vs rosuvastatin 10 mg, and atorvastatin 20 mg vs rosuvastatin 10 mg [ Time Frame: 12 months ]
- To investigate the changes of macrophage infiltration semi-quantitatively by OCT in comparisons of atorvastatin 60 mg vs atorvastatin 20 mg,atorvastatin 60 mg vs rosuvastatin 10 mg, and atorvastatin 20 mg vs rosuvastatin 10 mg [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01023607
|The Second Affiliated Hospital of Harbin Medical University|
|Harbin, Heilongjiang, China, 150081|
|Principal Investigator:||Bo Yu, MD,PhD||The Second Affiliated Hospital of Harbin Medical University|