Virtual Histology Findings and Effects of Varying Doses of Atorvastatin Treatment
NCT ID: NCT01200056
Last Updated: 2013-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2007-08-31
2010-06-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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.
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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Statin naive patient.
* No history of myocardial infarction. Angina free for at least 8 weeks.
Exclusion Criteria
* 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.
18 Years
85 Years
ALL
No
Sponsors
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Queen Mary Hospital, Hong Kong
OTHER
Pfizer
INDUSTRY
Prof. Stephen Lee
OTHER
Responsible Party
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Prof. Stephen Lee
Professor and Chief
Principal Investigators
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Prof. Stephen WL LEE, MD FRCP FACC
Role: PRINCIPAL_INVESTIGATOR
Department of Medicine, the University of Hong Kong, Queen Mary Hospital, Hospital Authority
Locations
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Department of Medicine, the University of Hong Kong, Queen Mary Hospital, Hospital Authority
Hong Kong SAR, Hong Kong, China
Countries
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References
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Other Identifiers
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HKCTR-517
Identifier Type: OTHER
Identifier Source: secondary_id
UW 07-266 (IRB HKU)
Identifier Type: -
Identifier Source: org_study_id