Evaluation of Statin-induced Lipid-rich Plaque Progression by Optical Coherence Tomography (OCT) Combined With Intravascular Ultrasound (IVUS)

• ClinicalTrials.gov Identifier: NCT01023607
• Recruitment Status: Completed
• First Posted: December 2, 2009
• Last Update Posted: September 11, 2013
• Sponsor: Harbin Medical University
• Information provided by (Responsible Party): Yu Bo, Harbin Medical University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease; Hyperlipidemia	Drug: Atorvastatin; Drug: Rosuvastatin	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (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)
• Study Start Date: December 2009
• Actual Primary Completion Date: August 2013
• Actual Study Completion Date: August 2013

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. 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 ]
2. 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 ]
3. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

China, Heilongjiang

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China, 150081

Sponsors and Collaborators

Harbin Medical University

Investigators

• Principal Investigator: Bo Yu, MD,PhD; The Second Affiliated Hospital of Harbin Medical University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Yu Bo, Bo Yu ,President, Department of Cardiology, Harbin Medical University
• ClinicalTrials.gov Identifier: NCT01023607
• Other Study ID Numbers: HMUOCT-STATIN
• First Posted: December 2, 2009
• Last Update Posted: September 11, 2013
• Last Verified: September 2013

Keywords provided by Yu Bo, Harbin Medical University:

optical coherence tomography; intravascular ultrasound; Coronary artery disease; Hyperlipidemia

Additional relevant MeSH terms:

Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Hyperlipidemias; Hyperlipoproteinemias; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Atorvastatin; Rosuvastatin Calcium; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors