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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

Primary Purpose

Acute Coronary Syndrome

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Zotalolimus Eluting Stent

Everolimus eluting stent

Ezetimibe 10mg & Simvastatin 40mg

Pravastatin 20mg

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

ZES group

EES group

Vytorin group

Mevalotin group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01857843

First Posted

May 15, 2013

Last Updated

February 4, 2014

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT01857843

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

160 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ZES group

Arm Type

Experimental

Arm Title

EES group

Arm Type

Active Comparator

Arm Title

Vytorin group

Arm Type

Experimental

Arm Title

Mevalotin group

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

Zotalolimus Eluting Stent

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Everolimus eluting stent

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Ezetimibe 10mg & Simvastatin 40mg

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

Pravastatin 20mg

Intervention Description

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 Outcome Measure Information:

Title

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

Time Frame

baseline and 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Severance Hospital

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

12. IPD Sharing Statement

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