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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

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ClinicalTrials.gov Identifier: NCT01857843
Recruitment Status : Completed
First Posted : May 20, 2013
Last Update Posted : February 5, 2014
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Device: Zotalolimus Eluting Stent Device: Everolimus eluting stent Drug: Ezetimibe 10mg & Simvastatin 40mg Drug: Pravastatin 20mg Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2009
Actual Primary Completion Date : November 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Ezetimibe

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)




Primary Outcome Measures :
  1. Quantitative change in fibrofatty component of plaque measured by VH-IVUS [ Time Frame: baseline and 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857843


Locations
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Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01857843    
Other Study ID Numbers: 1-2009-0032
First Posted: May 20, 2013    Key Record Dates
Last Update Posted: February 5, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Everolimus
Simvastatin
Ezetimibe
Pravastatin
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors