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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yu Bo, Harbin Medical University
ClinicalTrials.gov Identifier:
NCT01023607
First received: December 1, 2009
Last updated: September 10, 2013
Last verified: September 2013

December 1, 2009
September 10, 2013
December 2009
August 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01023607 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Evaluation of Statin-induced Lipid-rich Plaque Progression by Optical Coherence Tomography (OCT) Combined With Intravascular Ultrasound (IVUS)
Evaluation of Statin-induced Lipid-rich Plaque Progression by Optical Coherence Tomography (OCT)Combined With Intravascular Ultrasound (IVUS)

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Coronary Artery Disease
  • Hyperlipidemia
  • Drug: Atorvastatin
    Atorvastatin 20mg/day
  • Drug: Atorvastatin
    Atorvastatin, 60mg/day
  • Drug: Rosuvastatin
    Rosuvastatin,10mg/day
  • Active Comparator: Group A:
    Atorvastatin 20mg
    Intervention: Drug: Atorvastatin
  • Experimental: Group B:
    Atorvastatin 60mg
    Intervention: Drug: Atorvastatin
  • Active Comparator: Group C:
    Rosuvastatin 10mg
    Intervention: Drug: Rosuvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
August 2013
August 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01023607
HMUOCT-STATIN
No
Yu Bo, Harbin Medical University
Harbin Medical University
Not Provided
Principal Investigator: Bo Yu, MD,PhD The Second Affiliated Hospital of Harbin Medical University
Harbin Medical University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP