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

Acute Coronary Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01857843
• Other study ID #: 1-2009-0032
• Status: Completed
• Phase: Phase 4
• First received: May 15, 2013
• Last updated: February 4, 2014
• Start date: November 2009
• Est. completion date: January 2014

Study information

• Verified date: February 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

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.
• 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.

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

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative change in fibrofatty component of plaque measured by VH-IVUS		baseline and 3 months	No