drugset / Trial / NCT01857843

Early Effects of Intensive Lipid Lowering Treatment With Ezetimibe/ Simvastatin (Vytorin®) Assessed by Virtual Histology-Intravascular Ultrasound (VH-IVUS) and Optical Coherence Tomography (OCT) on Plaque Characteristics in Patients With Acute Coronary Syndrome

NCT01857843

Phase 4 Completed 160 enrolled Yonsei University
RandomizedParallel-groupOpen-labelTreatment

Summary

Objective: To evaluate the early effects of intensive lipid lowering treatments with ezetimibe/simvastatin (Vytorin®) for each component of coronary plaques. Study Design * Prospective, randomized, single-center study of each 80 subjects enrolled * Subjects with acute coronary syndrome who meet all inclusion and exclusion criteria will be enrolled. * Eligible subjects will be randomized 1:1 to A) Ezetimibe/Simvastatin (n=80) vs. B) Pravastatin (n=80), and each group of patients will be randomized further in a ratio of 1:1 to a) ZES (n=40) vs. b) EES (n=40), according to the type of stent used. * All subjects will undergo VH-IVUS at initial procedure. * Follow-up VH-IVUS will be performed at 3 months after index procedure. OCT at initial procedure and 3-months will be performed in available cases.

Timeline

Start
2009-11
Primary completion
2013-11
Completion
2014-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Ezetimibe Unknown 10 mg
Comparator Pravastatin Small molecule 20 mg
Subject Simvastatin Small molecule 40 mg