Evaluation of Statin-induced Lipid-rich Plaque Progression by Optical Coherence Tomography (OCT) Combined With Intravascular Ultrasound (IVUS)
Information source: Harbin Medical University
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Artery Disease; Hyperlipidemia
Intervention: Atorvastatin (Drug); Atorvastatin (Drug); Rosuvastatin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Harbin Medical University Official(s) and/or principal investigator(s):
Bo Yu, MD,PhD, Principal Investigator, Affiliation: The Second Affiliated Hospital of Harbin Medical University
Overall contact:
Bo Yu, MD,PhD, Phone: 86-045186605180, Email: yubodr@163.com
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.
Clinical Details
Official title: Evaluation of Statin-induced Lipid-rich Plaque Progression by Optical Coherence Tomography (OCT)Combined With Intravascular Ultrasound (IVUS)
Study design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: To compare the effects of atorvastatin 20mg and atorvastatin 60mg on the changes of FCT assessed by OCT and plaque burden by IVUS.
Secondary outcome: 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.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 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
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Age :18-75Y
2. Clinical indication for coronary angiography (CAG).
3. CAG demonstrates at least 1 de novo lesion with luminal diameter stenosis between 20%
and 70% (visual estimation).
4. OCT demonstrates the lesion is a lipid-rich plaque (FCT ≤200μm and lipid arc ≥100o).
5. LDL-C range between 70mg /dl and 160mg /dl.
6. Patient or legal guardian understands and agrees to comply with all specified study
requirements and provides written informed consent.
Exclusion criteria:
1. Life expectancy <12 months due to another medical condition.
2. Contraindication to the atorvastatin and rosuvastatin.
3. Creatinine levels more than 2. 0mg/dL or ESRD.
4. Severe hepatic dysfunction (AST and/or ALT more than 3 times the upper limit of
normal).
5. Congestive heart failure (left ventricle eject fraction ≤35%).
6. Female of childbearing potential with a positive pregnancy test within 7 days before
study, or lactating, or intends to become pregnant during the following 12 months.
7. The patient is likely to require coronary bypass surgery, cardiac transplantation,
surgical repair or replacement during the course.
Exit criteria
1. ALT/AST ≥ 3times upper limit of normal after enrollment.
2. Muscle ache/myopathy.
3. Lose follow-up.
4. Patient insists on exit.
Locations and Contacts
Bo Yu, MD,PhD, Phone: 86-045186605180, Email: yubodr@163.com
The Second Affiliated Hospital of Harbin Medical University, Harbin, Heilong jiang 150081, China; Recruiting
Bo Yu, MD,PhD, Phone: 86-045186605180, Email: yubodr@163.com
Bo Yu, MD,PhD, Principal Investigator
Additional Information
Starting date: December 2009
Last updated: December 3, 2009
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