Clinical 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)
Official title: RAndomized Comparison of Efficacy and Safety of Lipid-lowerING With Statin Monotherapy Versus Statin/Ezetimibe Combination for High-risk Cardiovascular Diseases (RACING Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Diseases
Cerebrovascular Disease
Peripheral Atherosclerotic Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-02-07
Enrollment: 3780
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Composite of cardiovascular death
timeFrame: Clinical status including medication and clinical events will be evaluated at 2 months.
measure: Composite of cardiovascular death
timeFrame: Clinical status including medication and clinical events will be evaluated at 6 months.
measure: Composite of cardiovascular death
timeFrame: Clinical status including medication and clinical events will be evaluated at every years until 3 years.
measure: Major cardiovascular event
timeFrame: Clinical status including medication and clinical events will be evaluated at 2 months.
measure: Major cardiovascular event
timeFrame: Clinical status including medication and clinical events will be evaluated at 6 months.
measure: Major cardiovascular event
timeFrame: Clinical status including medication and clinical events will be evaluated at every years until 3 years.
measure: Composite of nonfatal stroke
timeFrame: Clinical status including medication and clinical events will be evaluated at 2 months.
measure: Composite of nonfatal stroke
timeFrame: Clinical status including medication and clinical events will be evaluated at 6 months.
measure: Composite of nonfatal stroke
timeFrame: Clinical status including medication and clinical events will be evaluated at every years until 3 years.
Secondary outcomes:
measure: Clinical efficacy of lipid lowering treatment
timeFrame: 3years
measure: Clinical safety of lipid lowering treatment
timeFrame: 3years
measure: statin discontinuation and intolerance
timeFrame: 3years
measure: Clinical adverse events
timeFrame: 3years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Study officials:
References:
citation: Kim BK, Hong SJ, Lee YJ, Hong SJ, Yun KH, Hong BK, Heo JH, Rha SW, Cho YH, Lee SJ, Ahn CM, Kim JS, Ko YG, Choi D, Jang Y, Hong MK; RACING investigators. Long-term efficacy and safety of moderate-intensity statin with ezetimibe combination therapy versus high-intensity statin monotherapy in patients with atherosclerotic cardiovascular disease (RACING): a randomised, open-label, non-inferiority trial. Lancet. 2022 Jul 30;400(10349):380-390. doi: 10.1016/S0140-6736(22)00916-3. Epub 2022 Jul 18.