Virtual Histology Findings and Effects of Varying Doses of Atorvastatin Treatment

NCT01200056

Last updated date
Study Location
Department of Medicine, the University of Hong Kong, Queen Mary Hospital, Hospital Authority
Hong Kong SAR, Hong Kong, , China
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Coronary Disease, Interventional Ultrasonography, Hydroxymethylglutaryl-CoA Reductase Inhibitors
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-85 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patient aged 18 to 85 (not pregnant) requiring percutaneous intervention to coronary stenosis.

- Statin naive patient.

- No history of myocardial infarction. Angina free for at least 8 weeks.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Any history of previous statin treatment and myocardial infarction


- Current acute coronary syndrome or in cardiogenic shock


- Surgical bypass candidate


- Chronic total occlusion and very tortuous calcified arteries precluding safe IVUS
examination.


- Patient refused to give written informed consent.

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Coronary Disease, Interventional Ultrasonography, Hydroxymethylglutaryl-CoA Reductase InhibitorsVirtual Histology Findings and Effects of Varying Doses of Atorvastatin Treatment
NCT01200056
  1. Hong Kong SAR, Hong Kong
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Virtual Histology Findings and Effects of Varying Doses of Atorvastatin Treatment
Official Title  ICMJE A Prospective, Double-blinded, Randomised Study to Evaluate the Effects of Different Doses of Statin Treatment on Plaque Volume and Composition in Coronary Disease Determined by Virtual Histology Using Intravascular Ultrasound
Brief Summary

While statin treatment may induce plaque regression, the effect of statin on plaque composition with varying doses is unknown. This study assessed such effects by volumetric virtual histology intravascular ultrasound (VH-IVUS).

In this prospective, randomized, double-blinded pilot study, statin-naïve patients with stable angina requiring percutaneous coronary intervention (PCI) were randomized to receive 6 months of either atorvastatin 10mg or 40 mg daily. VH-IVUS was performed in all non-PCI lesions at baseline and 6 months; all analyses were performed by core laboratory.

Detailed Description

Statin therapy, especially at intensive doses, is beneficial in atherosclerotic coronary disease. Detecting subtle plaque regression after statin therapy is difficult by coronary angiogram; intravascular ultrasound (IVUS) is a far better method. Volumetric IVUS has been used in statin trials to evaluate plaque regression. Intensive statin therapy in the REVERSAL Trial and ASTEROID Trial appeared to achieve better regression outcomes. Stable fibrous plaque is likely to be responsible for stable ischemia, while unstable plaque (large lipid core, calcified nodule and necrotic core), thin-cap fibroatheroma, plaque erosion and plaque rupture may be responsible for acute coronary syndrome (ACS). In vivo tissue characterization of plaque composition is therefore important, yet in this regard grayscale IVUS is insufficient. The development of Virtual Histology (VH) utilizing IVUS generated radiofrequency backscattering signals to virtually separate plaque composition into 4 components corresponding to histopathology has made possible in vivo assessment of plaque composition and stability. We believed plaque regression and VH-IVUS plaque modification with statin therapy could be statin dose dependent, and may affect clinical outcomes. This study was designed to prove our hypothesis, utilizing VH-IVUS.

This study is the first prospective, randomised, double-blinded pilot study designed to investigate the varying statin dose effects on plaque regression and VH composition modulation. For ethical reasons, a placebo arm was not designed. Based on available data, clinically realistic doses of atorvastatin 10mg (low dose) and 40mg (moderate dose) were chosen. Only statin-naïve patients without previous history of myocardial infarction (MI) would be selected, aiming to show the "pure" effects of varying doses of statin and to better reveal the subtle differences in the changes.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Coronary Disease
  • Ultrasonography, Interventional
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
Intervention  ICMJE Drug: Atorvastatin 10mg versus 40mg.
2 arms comparing atorvastatin 10mg daily for 6 months to atorvastatin 40mg daily for 6 months. The primary endpoint would be the 6 months VH-IVUS findings and clinical outcomes.
Other Name: Lipitor 10mg versus 40mg daily for 6 months.
Study Arms  ICMJE
  • Active Comparator: Atorvastatin 10mg low dose
    Atorvastatin 10mg daily for 6 months and compared to atorvastatin 40mg daily in the other arm. The primary endpoint of 6 months VH-IVUS findings and clinical outcomes would be monitored and compared.
    Intervention: Drug: Atorvastatin 10mg versus 40mg.
  • Active Comparator: Atorvastatin 40mg moderate dose
    Atorvastatin 40mg daily for 6 months and compared to atorvastatin 10mg daily in the other arm. The primary endpoint of 6 months VH-IVUS findings and clinical outcomes would be monitored and compared.
    Intervention: Drug: Atorvastatin 10mg versus 40mg.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2010)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient aged 18 to 85 (not pregnant) requiring percutaneous intervention to coronary stenosis.
  • Statin naive patient.
  • No history of myocardial infarction. Angina free for at least 8 weeks.

Exclusion Criteria:

  • Any history of previous statin treatment and myocardial infarction
  • Current acute coronary syndrome or in cardiogenic shock
  • Surgical bypass candidate
  • Chronic total occlusion and very tortuous calcified arteries precluding safe IVUS examination.
  • Patient refused to give written informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01200056
Other Study ID Numbers  ICMJE UW 07-266 (IRB HKU)
HKCTR-517 ( Other Identifier: Clinical Trials Centre, HKU (www.HKClinicalTrials.com) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Stephen Lee, The University of Hong Kong
Study Sponsor  ICMJE Prof. Stephen Lee
Collaborators  ICMJE
  • Queen Mary Hospital, Hong Kong
  • Pfizer
Investigators  ICMJE
Principal Investigator:Prof. Stephen WL LEE, MD FRCP FACCDepartment of Medicine, the University of Hong Kong, Queen Mary Hospital, Hospital Authority
PRS Account The University of Hong Kong
Verification Date February 2013

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