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

Phase

N/A

Condition

Cardiovascular Disease

Atherosclerosis

Stroke

Treatment

N/A

Clinical Study ID

NCT03044665

4-2016-1025

Ages 19-80
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

Active liver disease or persistent unexplained serum AST or ALT elevation more than 2times 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, asassessed by the investigator
Inability to understand or read the informed content

Study Design

March 15, 2017

February 15, 2023

Connect with a study center

Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, 03722
Korea, Republic of
Active - Recruiting

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