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

Cardiovascular Diseases Clinical 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03044665
• Other study ID #: 4-2016-1025
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2017
• Est. completion date: February 15, 2023

Study information

• Verified date: January 2019
• Source: Yonsei University
• Contact: Yang-Soo Jang, MD, PhD
• Phone: 82-02-2228-8460
• Email: jangys1212[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3780
• Est. completion date: February 15, 2023
• Est. primary completion date: January 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cerebrovascular Disease
• Cerebrovascular Disorders
• Peripheral Atherosclerotic Disease

Intervention

Drug:
• Rosuvastatin
Subjects will start rosuvastatin 20 mg a day irrespective of previous lipid-lowering treatment or LDL-cholesterol level as current US guideline.
• Rosuvastatin plus ezetimibe
Subjects will start single combination pill of rosuvastatin 10 mg plus ezetimibe 10 mg a day irrespective of previous lipid-lowering treatment or LDL-cholesterol level.

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of cardiovascular death	Composite of cardiovascular death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.)	Clinical status including medication and clinical events will be evaluated at 2 months.
Primary	Composite of cardiovascular death	Composite of cardiovascular death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.)	Clinical status including medication and clinical events will be evaluated at 6 months.
Primary	Composite of cardiovascular death	Composite of cardiovascular death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.)	Clinical status including medication and clinical events will be evaluated at every years until 3 years.
Primary	Major cardiovascular event	Composite of cardiovascular death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.)	Clinical status including medication and clinical events will be evaluated at 2 months.
Primary	Major cardiovascular event	Composite of cardiovascular death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.)	Clinical status including medication and clinical events will be evaluated at 6 months.
Primary	Major cardiovascular event	Composite of cardiovascular death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.)	Clinical status including medication and clinical events will be evaluated at every years until 3 years.
Primary	Composite of nonfatal stroke	Composite of cardiovascular death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.)	Clinical status including medication and clinical events will be evaluated at 2 months.
Primary	Composite of nonfatal stroke	Composite of cardiovascular death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.)	Clinical status including medication and clinical events will be evaluated at 6 months.
Primary	Composite of nonfatal stroke	Composite of cardiovascular death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.)	Clinical status including medication and clinical events will be evaluated at every years until 3 years.
Secondary	Clinical efficacy of lipid lowering treatment	The proportion of participants whose LDL cholesterol is lower than 70mg/dL (1,2,3 years after enrollment); Composite of all death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.); Statin discontinuation or dose-reduction caused by intolerance; new-onset DM, muscle-related adverse events, gastrointestinal symptom, gallbladder-related event, major bleeding, cancer, new-onset neurocognitive disorder, cataract surgery	3years
Secondary	Clinical safety of lipid lowering treatment	The proportion of participants whose LDL cholesterol is lower than 70mg/dL (1,2,3 years after enrollment); Composite of all death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.); Statin discontinuation or dose-reduction caused by intolerance; new-onset DM, muscle-related adverse events, gastrointestinal symptom, gallbladder-related event, major bleeding, cancer, new-onset neurocognitive disorder, cataract surgery	3years
Secondary	statin discontinuation and intolerance	The proportion of participants whose LDL cholesterol is lower than 70mg/dL (1,2,3 years after enrollment); Composite of all death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.); Statin discontinuation or dose-reduction caused by intolerance; new-onset DM, muscle-related adverse events, gastrointestinal symptom, gallbladder-related event, major bleeding, cancer, new-onset neurocognitive disorder, cataract surgery	3years
Secondary	Clinical adverse events	The proportion of participants whose LDL cholesterol is lower than 70mg/dL (1,2,3 years after enrollment); Composite of all death, major cardiovascular event, nonfatal stroke (Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.); Statin discontinuation or dose-reduction caused by intolerance; new-onset DM, muscle-related adverse events, gastrointestinal symptom, gallbladder-related event, major bleeding, cancer, new-onset neurocognitive disorder, cataract surgery	3years