drugset / Trial / NCT03044665

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

NCT03044665

Unknown 3780 enrolled Yonsei University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2017-03-15
Primary completion
2022-01-15
Completion
2023-02-15

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Ezetimibe Unknown 10 mg Oral
Comparator Rosuvastatin Small molecule 10 mg Oral
Comparator Rosuvastatin Small molecule 20 mg Oral