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
  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 ]

Enrollment: 120
Study Start Date: December 2009
Study Completion Date: August 2013
Primary Completion Date: August 2013 (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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01023607

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

No publications provided

Responsible Party: Yu Bo, Bo Yu ,President, Department of Cardiology, Harbin Medical University
ClinicalTrials.gov Identifier: NCT01023607     History of Changes
Other Study ID Numbers: HMUOCT-STATIN
Study First Received: December 1, 2009
Last Updated: September 10, 2013
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:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Hyperlipidemias
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 July 29, 2014