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

Phase 4

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Device: Zotalolimus Eluting Stent; Device: Everolimus eluting stent; Drug: Ezetimibe 10mg & Simvastatin 40mg; Drug: Pravastatin 20mg

• Registration Number: NCT01857843
• Lead Sponsor: Yonsei University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2013-05-15
• Study First Submitted QC: 2013-05-15
• Study First Posted: 2013-05-20
• Primary Completion: 2013-11
• Study Completion: 2014-01
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-04
• Last Update Posted: 2014-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

General inclusion criteria

1. Acute coronary syndrome including unstable angina, acute non-ST elevation myocardial infarction and acute ST elevation myocardial infarction
2. Age of 20 years or older
3. Patients with signed informed consent

Angiographic inclusion criteria

1. De novo lesion without significant plaque (angiographic lumen diameter stenosis < 50%)
2. Reference vessel diameter ?> 3.0 mm by operator assessment
3. Segment length of 10-20 mm
4. Distance from the PCI site > 5.0mm (either proximal or distal)
5. Available for serial high quality IVUS studies of the entire segment.

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Exclusion Criteria

1. Failed PCI
2. Recommended coronary artery bypass grafting (CABG)
3. Cardiogenic Shock
4. Administration of lipid lowering agents before enrollment
5. Significant hepatic dysfunction (3 times normal reference values)
6. Significant renal dysfunction (Serum creatinine > 2.0 mg/dl)
7. Significant leukopenia, thrombocytopenia, anemia, or known bleeding diathesis
8. Pregnant women or women with potential childbearing
9. Saphenous vein graft

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ZES group	Zotalolimus Eluting Stent	-
EES group	Everolimus eluting stent	-
Vytorin group	Ezetimibe 10mg & Simvastatin 40mg	-
Mevalotin group	Pravastatin 20mg	-

Primary Outcome Measures

Name	Time	Method
Quantitative change in fibrofatty component of plaque measured by VH-IVUS	baseline and 3 months

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of