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OpenTrials
Completed

NCT Number: 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

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

General inclusion criteria

  • 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

Angiographic inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

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.

  • Ezetimibe 10mg/Simvastatin 40mg (Vytorin®, MSD)
  • Pravastatin 20mg (mevalotin®, BMS)

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.

  • Ezetimibe 10mg/Simvastatin 40mg (Vytorin®, MSD)
  • Pravastatin 20mg (mevalotin®, BMS)

Primary outcomes

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

    Time frame: baseline and 3 months

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
May 20, 2013
Registry last updated
Feb 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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