RAndomized Comparison of Efficacy and Safety of Lipid-lowerING With Statin Monotherapy Versus Statin/Ezetimibe Combination for High-risk Cardiovascular Diseases (RACING Trial)

Yonsei University

Status: Unknown

Conditions: Cerebrovascular Disease; Peripheral Atherosclerotic Disease; Cardiovascular Diseases

Treatments: Drug: Rosuvastatin; Drug: Rosuvastatin plus ezetimibe

Study type: Interventional

Funder types: Other

Identifiers

NCT03044665

4-2016-1025

Details and patient eligibility

About

The clinical efficacy of LDL-lowering therapy have been proven with strong evidences and more emphasized. However, there are also growing concerns that high-intensity statin would be related to increased risk of adverse effects. In addition, there was an inconsistency of efficacy of statin according to ethnic population. Asian population showed more profound LDL reduction not only from high potent statin but from moderate to low potent statin. Conventional strategies for lowering LDL-cholesterol was focused on statins, therefore doubling of previously described dose of statin would be common way in patients with inadequate lowering LDL-cholesterol level. Additive ezetimibe will also an alternative strategy not only to lower LDL-cholesterol level and also to reduce the need of dosage of high-intensity statin to fulfill sufficient LDL-cholesterol lowering effect. We will evaluate whether additive ezetimibe with rosuvastatin will have comparable clinical efficacy in terms of clinical outcomes and goal attainment of LDL-C compared to rosuvastatin monotherapy.

Enrollment: 3,780 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 19-80 years
• Documented CVD (cardiovascular disease), previous MI(Myocardial Infarction), ACS (Acute Coronary Syndrome), coronary revascularization and other arterial revascularization procedures, ischemic stroke, or PAD (peripheral artery disease)

Exclusion criteria

• Active liver disease or persistent unexplained serum AST or ALT elevation more than 2 times the upper limit of normal range
• Allergy or hypersensitivity to any statin or ezetimibe
• Solid organ transplantation recipient
• History of any adverse drug reaction requiring discontinuation of statin
• Pregnant women, women with potential childbearing, or lactating women
• Life expectancy less than 3 years
• Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
• Inability to understand or read the informed content

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,780 participants in 2 patient groups

High-intensity statin monotherapy

Active Comparator group

Description:

Statin monotherapy

Treatment:

Drug: Rosuvastatin

Statin plus ezetimibe combination therapy

Experimental group

Description:

Statin plus ezetimibe combination therapy

Treatment:

Drug: Rosuvastatin plus ezetimibe