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

NCT01023607 | Completed Phase 4

• 1 other identifier: HMUOCT-STATIN
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Hyperlipidemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• To compare the effects of atorvastatin 20mg and atorvastatin 60mg on the changes of FCT assessed by OCT and plaque burden by IVUS.

  12 months after enrollment

Secondary Outcomes (3)

• 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.

  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

  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

  12 months

Study Arms (3)

Group A:

ACTIVE COMPARATOR

Atorvastatin 20mg

Drug: Atorvastatin

Group B:

EXPERIMENTAL

Atorvastatin 60mg

Drug: Atorvastatin

Group C:

ACTIVE COMPARATOR

Rosuvastatin 10mg

Drug: Rosuvastatin

Interventions

Atorvastatin DRUG

Atorvastatin 20mg/day

Group A:

Rosuvastatin DRUG

Rosuvastatin,10mg/day

Group C:

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harbin Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150081, China

Location

Related Publications (1)

• 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.

  PMID: 27871242 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Hyperlipidemias

Interventions

Atorvastatin; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines

Study Officials

• Bo Yu, MD,PhD

  The Second Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bo Yu ,President, Department of Cardiology

Study Record Dates

• First Submitted: December 1, 2009
• First Posted: December 2, 2009
• Study Start: December 1, 2009
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: September 11, 2013

Record last verified: 2013-09

Locations

CN (1)