RAndomized Comparison of efficacy and safety of lipid-lowerING with statin monotherapy versus statin/ezetimibe combination for high-risk cardiovascular diseases (RACING trial)
Not Applicable
Completed
- Conditions
- Diseases of the circulatory system
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 3780
Inclusion Criteria
1. Age 19-80 years
2. Documented CVD, previous MI, ACS, coronary revascularization and other arterial revascularization procedures, ischemic stroke, or PAD
Exclusion Criteria
1. Active liver disease or persistent unexplained serum AST or ALT elevation more than 2 times the upper limit of normal range
2. Allergy or hypersensitivity to any statin or ezetimibe
3. Solid organ transplantation recipient
4. History of any adverse drug reaction requiring discontinuation of statin
5. Pregnant women, women with potential childbearing, or lactating women
6. Life expectancy less than 3 years
7. Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
8. Inability to understand or read the informed content
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method cardiovascular death;major cardiovascular event,(Major cardiovascular event include any coronary or peripheral revascularization and hospitalization for any cardiovascular events including ischemic heart disease, heart failure, peripheral arterial disease.);nonfatal stroke
- Secondary Outcome Measures
Name Time Method Proportion of goal attainment with lowering LDL-cholesterol less than 70 mg/dL;Clinical efficacy of lipid lowering treatment;statin discontinuation and intolerance;Clinical adverse events (new-onset DM, muscle-related adverse events, gastrointestinal symptom, gallbladder-related event, major bleeding, cancer, new-onset neurocognitive disorder, cataract surgery)