ST-Segment Elevation Myocardial Infarction Clinical Trial
Official title:
The Effect Of Ezetimibe In Addition To Optimal Cholesterol-Lowering Statin Therapy On The Plaque Composition In Patients With Acute Myocardial Infarction - Assessed By Optical Coherence Tomography And Intravascular Ultrasound.
The purpose of the study is to examine the effect of the cholesterol lowering agent
Ezetimibe when used in addition to optimal treatment with Atorvastatin in patients with
acute ST-Elevation Myocardial Infarction (STEMI) who have not been in prior statin therapy.
An area with arteriosclerosis not demanding intervention in a coronary vessel other than the
infarct related is used as measuring point and is examined at time of the infarction and
after 12 month using intravascular ultrasound and optical coherence tomography. At the same
time the same techniques are used to examine the implanted stent.
Optical coherence tomography (OCT) and intravascular ultrasound (IVUS) with tissue
characterization (IVUS-TC) are relatively new expansions to intravascular assessments, and
has the capacity to assess plaque composition and, potentially, to identify vulnerable
plaques. One of the mechanisms by which statins improve patient outcomes may be by changing
the composition of a "vulnerable" plaque. The main effect is believed to rely on a lowering
of LDL-c. The question is whether a further reduction of LDL by adding ezetimibe to optimal
cholesterol lowering therapy using statins may result in further plaque stabilization or
reduction. This is the hypothesis of the current study.
100 patients are randomized to Ezetimibe 10 mg per day or placebo. All patients are treated
with Atorvastatin 80 mg. OCT and IVUS are performed at inclusion (typically the day after
Primary PCI) and again at follow-up after 12 month.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
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