Evaluation of Statin-induced Lipid-rich Plaque Progression by Optical Coherence Tomography (OCT) Combined With Intravascular Ultrasound (IVUS)
NCT ID: NCT01023607
Last Updated: 2013-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
120 participants
INTERVENTIONAL
2009-12-31
2013-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Group A:
Atorvastatin 20mg
Atorvastatin
Atorvastatin 20mg/day
Group B:
Atorvastatin 60mg
Atorvastatin
Atorvastatin, 60mg/day
Group C:
Rosuvastatin 10mg
Rosuvastatin
Rosuvastatin,10mg/day
Interventions
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Atorvastatin
Atorvastatin 20mg/day
Atorvastatin
Atorvastatin, 60mg/day
Rosuvastatin
Rosuvastatin,10mg/day
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Harbin Medical University
OTHER
Responsible Party
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Yu Bo
Bo Yu ,President, Department of Cardiology
Principal Investigators
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Bo Yu, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
The Second Affiliated Hospital of Harbin Medical University
Locations
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The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Countries
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References
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Dong N, Xie Z, Wang W, Dai J, Sun M, Pu Z, Tian J, Yu B. Comparison of coronary arterial lumen dimensions on angiography and plaque characteristics on optical coherence tomography images and their changes induced by statin. BMC Med Imaging. 2016 Nov 22;16(1):63. doi: 10.1186/s12880-016-0166-4.
Other Identifiers
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HMUOCT-STATIN
Identifier Type: -
Identifier Source: org_study_id