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Virtual Histology Findings and Effects of Varying Doses of Atorvastatin Treatment

NCT01200056 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2013-02-28

No results posted yet for this study

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.

Conditions

  • Coronary Disease
  • Ultrasonography, Interventional
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors

Interventions

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.

Sponsors & Collaborators

  • Queen Mary Hospital, Hong Kong

    collaborator OTHER

  • Pfizer

    collaborator INDUSTRY

  • Prof. Stephen Lee

    lead OTHER

Principal Investigators

  • Prof. Stephen WL LEE, MD FRCP FACC · Department of Medicine, the University of Hong Kong, Queen Mary Hospital, Hospital Authority

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2009-11-30
Completion
2010-06-30

Countries

  • China

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01200056 on ClinicalTrials.gov