Evaluation of Statin-induced Lipid-rich Plaque Progression by Optical Coherence Tomography (OCT) Combined With Intravascular Ultrasound (IVUS)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Harbin Medical University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Harbin Medical University
Information provided by:
Harbin Medical University
ClinicalTrials.gov Identifier:
NCT01023607
First received: December 1, 2009
Last updated: December 3, 2009
Last verified: December 2009
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease Hyperlipidemia |
Drug: Atorvastatin Drug: Rosuvastatin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Evaluation of Statin-induced Lipid-rich Plaque Progression by Optical Coherence Tomography (OCT)Combined With Intravascular Ultrasound (IVUS) |
Resource links provided by NLM:
Further study details as provided by Harbin Medical University:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 120 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Group A:
Atorvastatin 20mg
|
Drug: Atorvastatin
Atorvastatin 20mg/day
|
|
Experimental: Group B:
Atorvastatin 60mg
|
Drug: Atorvastatin
Atorvastatin, 60mg/day
|
|
Active Comparator: Group C:
Rosuvastatin 10mg
|
Drug: Rosuvastatin
Rosuvastatin,10mg/day
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age :18-75Y
- Clinical indication for coronary angiography (CAG).
- CAG demonstrates at least 1 de novo lesion with luminal diameter stenosis between 20% and 70% (visual estimation).
- OCT demonstrates the lesion is a lipid-rich plaque (FCT ≤200μm and lipid arc ≥100o).
- LDL-C range between 70mg /dl and 160mg /dl.
- Patient or legal guardian understands and agrees to comply with all specified study requirements and provides written informed consent.
Exclusion criteria:
- Life expectancy <12 months due to another medical condition.
- Contraindication to the atorvastatin and rosuvastatin.
- Creatinine levels more than 2.0mg/dL or ESRD.
- Severe hepatic dysfunction (AST and/or ALT more than 3 times the upper limit of normal).
- Congestive heart failure (left ventricle eject fraction ≤35%).
- 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.
- The patient is likely to require coronary bypass surgery, cardiac transplantation, surgical repair or replacement during the course.
Exit criteria
- ALT/AST ≥ 3times upper limit of normal after enrollment.
- Muscle ache/myopathy.
- Lose follow-up.
- Patient insists on exit.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01023607
Contacts
| Contact: Bo Yu, MD,PhD | 86-045186605180 | yubodr@163.com |
Locations
| China, Heilong jiang | |
| The Second Affiliated Hospital of Harbin Medical University | Recruiting |
| Harbin, Heilong jiang, China, 150081 | |
| Contact: Bo Yu, MD,PhD 86-045186605180 yubodr@163.com | |
| Principal Investigator: Bo Yu, MD,PhD | |
Sponsors and Collaborators
Harbin Medical University
Investigators
| Principal Investigator: | Bo Yu, MD,PhD | The Second Affiliated Hospital of Harbin Medical University |
More Information
No publications provided
| Responsible Party: | Bo Yu ,President, Department of Cardiology of The Second Affiliated Hospital of Harbin Medical University |
| ClinicalTrials.gov Identifier: | NCT01023607 History of Changes |
| Other Study ID Numbers: | HMUOCT-STATIN |
| Study First Received: | December 1, 2009 |
| Last Updated: | December 3, 2009 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Harbin Medical University:
|
optical coherence tomography intravascular ultrasound Coronary artery disease Hyperlipidemia |
Additional relevant MeSH terms:
|
Hyperlipidemias Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |
Atorvastatin Rosuvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013