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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01023607
• Other study ID #: HMUOCT-STATIN
• Status: Completed
• Phase: Phase 4
• First received: December 1, 2009
• Last updated: September 10, 2013
• Start date: December 2009
• Est. completion date: August 2013

Study information

• Verified date: September 2013
• Source: Harbin Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Hyperlipidemia
• Hyperlipidemias
• Myocardial Ischemia

Intervention

Drug:
• Atorvastatin
Atorvastatin 20mg/day
• Atorvastatin
Atorvastatin, 60mg/day
• Rosuvastatin
Rosuvastatin,10mg/day

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes