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

February 4, 2014 updated by: Yonsei University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ZES group
Device: 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.
Active Comparator: EES group
Device: 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.
Experimental: Vytorin group
Drug: 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)
Active Comparator: Mevalotin group
Drug: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quantitative change in fibrofatty component of plaque measured by VH-IVUS
Time Frame: baseline and 3 months
baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

May 15, 2013

First Submitted That Met QC Criteria

May 15, 2013

First Posted (Estimate)

May 20, 2013

Study Record Updates

Last Update Posted (Estimate)

February 5, 2014

Last Update Submitted That Met QC Criteria

February 4, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-2009-0032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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