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Effect of Statins on the Radial Intima-media Thickness After Transradial Angioplasty

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
transradial coronary intervention
Sponsored by
Chungnam National University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease focused on measuring Coronary artery disease, Coronary intervention, intima-media thickness

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing coronary intervention via the radial artery

Exclusion Criteria:

  • Contraindication to statins
  • Left ventricular ejection fraction less than 30%
  • Recent history of hematologic disease or leukocyte count <3000/mm3 and/or platelet <100 000/mm3
  • Hepatic dysfunction with AST or ALT >3 times the upper normal reference limit
  • History of renal dysfunction or a serum creatinine level >2.0 mg/dL
  • Serious noncardiac comorbid disease with a life expectancy <1 year
  • Inability to follow the protocol

Sites / Locations

  • Chungnam National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Atorvastatin

Simvastatin/Ezetimibe

Arm Description

Group receiving atorvastatin 20mg/day

Group receiving simvastatin/ezetimibe 10/10mg

Outcomes

Primary Outcome Measures

Difference of IMT between two groups

Secondary Outcome Measures

Difference of epicardial fat thickness Difference of cholesterol level

Full Information

First Posted
August 4, 2009
Last Updated
August 4, 2009
Sponsor
Chungnam National University
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1. Study Identification

Unique Protocol Identification Number
NCT00952770
Brief Title
Effect of Statins on the Radial Intima-media Thickness After Transradial Angioplasty
Official Title
Effect of Statins on the Progression of the Intima-media Thickness of the Radial Artery After Radial Angioplasty
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Chungnam National University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The first event of the atherosclerotic plaque formation is the accumulation of the low density lipoprotein-cholesterol (LDL-cholesterol) in to the intima of the arterial wall. After accumulation of the LDL-cholesterol, the oxidation of the LDL-cholesterol particles and recruitment of monocytes to the intima and media are the next steps. The thickening of intima-media thickness (IMT) is resulted from these initial events. The IMT can be easily measured by high-resolution ultrasonography in various arteries including carotid, brachial and radial arteries. The increased carotid IMT can be used as a non-invasive independent parameter indicating increased cardiovascular mortality. Some investigators reported increased radial IMT is associated with increased early failure of the radiocephalic arteriovenous fistula in the hemodialysis patients. Moreover, radial IMT is increased in patients underwent radial artery intervention because of denudation injury of the radial artery. Recently, the use of statin can halt the progression of the carotid IMT progression. However, it is unknown that the use of statin can prevent the progression of radial IMT after the transradial coronary intervention. The investigators want to evaluate the effect of statins on the progression of the radial IMT after the transradial intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary artery disease, Coronary intervention, intima-media thickness

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Atorvastatin
Arm Type
Experimental
Arm Description
Group receiving atorvastatin 20mg/day
Arm Title
Simvastatin/Ezetimibe
Arm Type
Active Comparator
Arm Description
Group receiving simvastatin/ezetimibe 10/10mg
Intervention Type
Procedure
Intervention Name(s)
transradial coronary intervention
Intervention Description
percutaneous coronary intervention with transradial approach
Primary Outcome Measure Information:
Title
Difference of IMT between two groups
Time Frame
1 month, 6 months
Secondary Outcome Measure Information:
Title
Difference of epicardial fat thickness Difference of cholesterol level
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing coronary intervention via the radial artery Exclusion Criteria: Contraindication to statins Left ventricular ejection fraction less than 30% Recent history of hematologic disease or leukocyte count <3000/mm3 and/or platelet <100 000/mm3 Hepatic dysfunction with AST or ALT >3 times the upper normal reference limit History of renal dysfunction or a serum creatinine level >2.0 mg/dL Serious noncardiac comorbid disease with a life expectancy <1 year Inability to follow the protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jae-Hyeong Park, MD, PhD
Phone
82-42-280-7167
Email
jaehpark@cnuh.co.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Si Wan Choi, MD, PhD
Phone
82-42-280-8237
Email
csw1967@cnuh.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae-Hyeong Park, MD, PhD
Organizational Affiliation
Chungnam National University, Chungnam National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae-Hyeong Park, MD, PhD
Phone
82-42-280-7167
Email
jaehpark@cnuh.co.kr

12. IPD Sharing Statement

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Effect of Statins on the Radial Intima-media Thickness After Transradial Angioplasty

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