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

Chungnam National University

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease

Treatments: Procedure: transradial coronary intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT00952770

CNUH-09-07-60

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Atorvastatin

Experimental group

Description:

Group receiving atorvastatin 20mg/day

Treatment:

Procedure: transradial coronary intervention

Simvastatin/Ezetimibe

Active Comparator group

Description:

Group receiving simvastatin/ezetimibe 10/10mg

Treatment:

Procedure: transradial coronary intervention