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
NCT ID: NCT01857843
Last Updated: 2014-02-05
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
160 participants
INTERVENTIONAL
2009-11-30
2014-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ZES group
Zotalolimus Eluting Stent
Permuted block randomization into 4 groups according to the type of drug and stent will be carried out in a ratio of 1:1:1:1(i.e.,Vytorin-ZES, Vytorin-EES, mevalotin-ZES, or mevalotin-EES) for balanced randomization.
Patients with native coronary arteries who fulfill all enrollment criteria for OCT study will be randomized to receive either ZES (Endeavor®-Sprint or Resolute-integrity) or EES (Xience®) in a ratio of 1:1.
EES group
Everolimus eluting stent
Permuted block randomization into 4 groups according to the type of drug and stent will be carried out in a ratio of 1:1:1:1(i.e.,Vytorin-ZES, Vytorin-EES, mevalotin-ZES, or mevalotin-EES) for balanced randomization.
Patients with native coronary arteries who fulfill all enrollment criteria for OCT study will be randomized to receive either ZES (Endeavor®-Sprint or resolute-integrity) or EES (Xience®) in a ratio of 1:1.
Vytorin group
Ezetimibe 10mg & Simvastatin 40mg
Permuted block randomization into 4 groups according to the type of drug and stent will be carried out in a ratio of 1:1:1:1(i.e.,Vytorin-ZES, Vytorin-EES, mevalotin-ZES, or mevalotin-EES) for balanced randomization.
Patients will be randomized in a ratio of 1:1 according to the two different types of lipid lowering treatment.
1. Ezetimibe 10mg/Simvastatin 40mg (Vytorin®, MSD)
2. Pravastatin 20mg (mevalotin®, BMS)
Mevalotin group
Pravastatin 20mg
Permuted block randomization into 4 groups according to the type of drug and stent will be carried out in a ratio of 1:1:1:1(i.e.,Vytorin-ZES, Vytorin-EES, mevalotin-ZES, or mevalotin-EES) for balanced randomization.
Patients will be randomized in a ratio of 1:1 according to the two different types of lipid lowering treatment.
1. Ezetimibe 10mg/Simvastatin 40mg (Vytorin®, MSD)
2. Pravastatin 20mg (mevalotin®, BMS)
Interventions
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Zotalolimus Eluting Stent
Permuted block randomization into 4 groups according to the type of drug and stent will be carried out in a ratio of 1:1:1:1(i.e.,Vytorin-ZES, Vytorin-EES, mevalotin-ZES, or mevalotin-EES) for balanced randomization.
Patients with native coronary arteries who fulfill all enrollment criteria for OCT study will be randomized to receive either ZES (Endeavor®-Sprint or Resolute-integrity) or EES (Xience®) in a ratio of 1:1.
Everolimus eluting stent
Permuted block randomization into 4 groups according to the type of drug and stent will be carried out in a ratio of 1:1:1:1(i.e.,Vytorin-ZES, Vytorin-EES, mevalotin-ZES, or mevalotin-EES) for balanced randomization.
Patients with native coronary arteries who fulfill all enrollment criteria for OCT study will be randomized to receive either ZES (Endeavor®-Sprint or resolute-integrity) or EES (Xience®) in a ratio of 1:1.
Ezetimibe 10mg & Simvastatin 40mg
Permuted block randomization into 4 groups according to the type of drug and stent will be carried out in a ratio of 1:1:1:1(i.e.,Vytorin-ZES, Vytorin-EES, mevalotin-ZES, or mevalotin-EES) for balanced randomization.
Patients will be randomized in a ratio of 1:1 according to the two different types of lipid lowering treatment.
1. Ezetimibe 10mg/Simvastatin 40mg (Vytorin®, MSD)
2. Pravastatin 20mg (mevalotin®, BMS)
Pravastatin 20mg
Permuted block randomization into 4 groups according to the type of drug and stent will be carried out in a ratio of 1:1:1:1(i.e.,Vytorin-ZES, Vytorin-EES, mevalotin-ZES, or mevalotin-EES) for balanced randomization.
Patients will be randomized in a ratio of 1:1 according to the two different types of lipid lowering treatment.
1. Ezetimibe 10mg/Simvastatin 40mg (Vytorin®, MSD)
2. Pravastatin 20mg (mevalotin®, BMS)
Eligibility Criteria
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Inclusion Criteria
2. Age of 20 years or older
3. Patients with signed informed consent
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.
Exclusion Criteria
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
20 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Severance Hospital
Seoul, Seoul, South Korea
Countries
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Other Identifiers
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1-2009-0032
Identifier Type: -
Identifier Source: org_study_id
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