CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
Atorvastatin 10mg versus 40mg.drug
Likely dose
Atorvastatin 10mg versus 40mg.from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01200056
NCT01200056Phase 4Completed
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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

Prof. Stephen Lee·interventional·Posted Sep 13, 2010·Updated Feb 28, 2013

In Brief

A Phase 4 clinical trial evaluating Atorvastatin 10mg versus 40mg. for Coronary Disease and 2 related conditions. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Disease, Ultrasonography, Interventional, Hydroxymethylglutaryl-CoA Reductase Inhibitors
CountriesChina
CollaboratorsQueen Mary Hospital, Hong Kong, Pfizer

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 13, 2010
Enrollment StartAug 1, 2007
Primary CompletionNov 1, 2009
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.8 years ago

Interventions

Atorvastatin 10mg versus 40mg.drug

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.