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 | Completed Phase 4

• 1 other identifier: 1-2009-0032
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• Quantitative change in fibrofatty component of plaque measured by VH-IVUS

  baseline and 3 months

Study Arms (4)

ZES group

EXPERIMENTAL

Device: Zotalolimus Eluting Stent

EES group

ACTIVE COMPARATOR

Device: Everolimus eluting stent

Vytorin group

EXPERIMENTAL

Drug: Ezetimibe 10mg & Simvastatin 40mg

Mevalotin group

ACTIVE COMPARATOR

Drug: Pravastatin 20mg

Interventions

Zotalolimus Eluting Stent DEVICE

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.

ZES group

Everolimus eluting stent DEVICE

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

Ezetimibe 10mg & Simvastatin 40mg DRUG

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)

Vytorin group

Pravastatin 20mg DRUG

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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute coronary syndrome including unstable angina, acute non-ST elevation myocardial infarction and acute ST elevation myocardial infarction
• Age of 20 years or older
• Patients with signed informed consent
• De novo lesion without significant plaque (angiographic lumen diameter stenosis \< 50%)
• Reference vessel diameter ?\> 3.0 mm by operator assessment
• Segment length of 10-20 mm
• Distance from the PCI site \> 5.0mm (either proximal or distal)
• Available for serial high quality IVUS studies of the entire segment.

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Ezetimibe; Simvastatin; Pravastatin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2013
• First Posted: May 20, 2013
• Study Start: November 1, 2009
• Primary Completion: November 1, 2013
• Study Completion: January 1, 2014
• Last Updated: February 5, 2014

Record last verified: 2014-02

Locations

KR (1)