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

NCT ID: NCT00952770

Last Updated: 2009-08-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Atorvastatin

Group receiving atorvastatin 20mg/day

Group Type: EXPERIMENTAL

transradial coronary intervention

Intervention Type: PROCEDURE

percutaneous coronary intervention with transradial approach

Simvastatin/Ezetimibe

Group receiving simvastatin/ezetimibe 10/10mg

Group Type: ACTIVE_COMPARATOR

transradial coronary intervention

Intervention Type: PROCEDURE

percutaneous coronary intervention with transradial approach

Interventions

transradial coronary intervention

percutaneous coronary intervention with transradial approach

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chungnam National University

OTHER

Sponsor Role: lead

Responsible Party

Chungnam National University, Chungnam National University Hospital

Principal Investigators

Jae-Hyeong Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Chungnam National University, Chungnam National University Hospital

Locations

Chungnam National University Hospital

Daejeon, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Jae-Hyeong Park, MD, PhD

Role: CONTACT

jaehpark@cnuh.co.kr

82-42-280-7167

Si Wan Choi, MD, PhD

Role: CONTACT

csw1967@cnuh.co.kr

82-42-280-8237

Facility Contacts

Jae-Hyeong Park, MD, PhD

Role: primary

jaehpark@cnuh.co.kr

82-42-280-7167

Other Identifiers

CNUH-09-07-60

Identifier Type: -

Identifier Source: org_study_id