Cardiovascular DiseasesNCT03044665
RAndomized Comparison of Efficacy and Safety of Lipid-lowerING With Statin Monotherapy Versus Statin/Ezetimibe Combination for High-risk Cardiovascular Diseases (RACING Trial)
A study testing Rosuvastatin and Rosuvastatin plus ezetimibe in people with Cardiovascular Diseases and Cerebrovascular Disease, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Cardiovascular Diseases, Cerebrovascular Disease, Peripheral Atherosclerotic Disease
- What is being tested?
- Rosuvastatin and Rosuvastatin plus ezetimibe
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,780 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Mar 2017to 15 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, 03722
Yang-Soo Jang, MD, PhD
About this study
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.
- Being tested
- Rosuvastatin, Rosuvastatin plus ezetimibe
- Medical subject headings
- Cardiovascular Diseases, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Subjects will start rosuvastatin 20 mg a day irrespective of previous lipid-lowering treatment or LDL-cholesterol level as current US guideline.
Rosuvastatin plus ezetimibeDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity statin monotherapy | Active comparator | Statin monotherapy Receives: Drug: Rosuvastatin |
| Statin plus ezetimibe combination therapy | Experimental | Statin plus ezetimibe combination therapy Receives: Drug: Rosuvastatin plus ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: Clinical status including medication and clinical events will be evaluated at 2 months.
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.)
Measured: Clinical status including medication and clinical events will be evaluated at 6 months.
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.)
Measured: Clinical status including medication and clinical events will be evaluated at every years until 3 years.
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.)
Measured: Clinical status including medication and clinical events will be evaluated at 2 months.
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.)
Measured: Clinical status including medication and clinical events will be evaluated at 6 months.
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.)
Measured: Clinical status including medication and clinical events will be evaluated at every years until 3 years.
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.)
Measured: Clinical status including medication and clinical events will be evaluated at 2 months.
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.)
Measured: Clinical status including medication and clinical events will be evaluated at 6 months.
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.)
Measured: Clinical status including medication and clinical events will be evaluated at every years until 3 years.
Secondary outcomes (4)
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
Measured: 3years
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
Measured: 3years
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
Measured: 3years
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
Measured: 3years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start15 Mar 2017
- Primary completion15 Jan 2022 (estimated)
- Study completion15 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,780 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03044665
- Sponsor's protocol ID
- 4-2016-1025
- Status last verified
- Jan 2019
- First submitted
- 1 Feb 2017
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee JH, Ahn SG, Jeon HS, Lee JW, Youn YJ, Lee YJ, Lee SJ, Hong SJ, Ahn CM, Ko YG, Kim JS, Choi D, Hong MK, Jang Y, Kim BK. Remnant cholesterol as a residual risk in atherosclerotic cardiovascular disease patients under statin-based lipid-lowering therapy: A post hoc analysis of the RACING trial. J Clin Lipidol. 2024 Nov-Dec;18(6):e905-e914. doi: 10.1016/j.jacl.2024.07.005. Epub 2024 Jul 27.
PubMed 39322526Kim BG, Lee SJ, Lee YJ, You SC, Hong SJ, Yun KH, Hong BK, Heo JH, Rha SW, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Jang Y, Cho YH, Kim JS. Effect of moderate-intensity statin with ezetimibe combination vs. high-intensity statin therapy according to sex in patients with atherosclerosis. Sci Rep. 2023 Nov 17;13(1):20157. doi: 10.1038/s41598-023-47505-x.
PubMed 37978309Lee SJ, Cha JJ, Choi WG, Lee WS, Jeong JO, Choi S, Cho YH, Park W, Yoon CH, Lee YJ, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Jang Y, Hong SJ, Kim JS; RACING Investigators. Moderate-Intensity Statin With Ezetimibe Combination Therapy vs High-Intensity Statin Monotherapy in Patients at Very High Risk of Atherosclerotic Cardiovascular Disease: A Post Hoc Analysis From the RACING Randomized Clinical Trial. JAMA Cardiol. 2023 Sep 1;8(9):853-858. doi: 10.1001/jamacardio.2023.2222.
PubMed 37531130Park JI, Lee SJ, Hong BK, Cho YH, Shin WY, Lim SW, Kang WC, Park Y, Lee SY, Lee YJ, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Jang Y, Kim JS; RACING investigators. Efficacy and safety of moderate-intensity statin with ezetimibe combination therapy in patients after percutaneous coronary intervention: a post-hoc analysis of the RACING trial. EClinicalMedicine. 2023 Apr 4;58:101933. doi: 10.1016/j.eclinm.2023.101933. eCollection 2023 Apr.
PubMed 37090440Lee SH, Lee YJ, Heo JH, Hur SH, Choi HH, Kim KJ, Kim JH, Park KH, Lee JH, Choi YJ, Lee SJ, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Jang Y, Kim JS. Combination Moderate-Intensity Statin and Ezetimibe Therapy for Elderly Patients With Atherosclerosis. J Am Coll Cardiol. 2023 Apr 11;81(14):1339-1349. doi: 10.1016/j.jacc.2023.02.007.
PubMed 37019580Lee YJ, Cho JY, You SC, Lee YH, Yun KH, Cho YH, Shin WY, Im SW, Kang WC, Park Y, Lee SY, Lee SJ, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Jang Y, Kim JS. Moderate-intensity statin with ezetimibe vs. high-intensity statin in patients with diabetes and atherosclerotic cardiovascular disease in the RACING trial. Eur Heart J. 2023 Mar 14;44(11):972-983. doi: 10.1093/eurheartj/ehac709.
PubMed 36529993Kim 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.
PubMed 35863366
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03044665
- Acronym / sponsor ID
- 4-2016-1025
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,780 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 15 Jan 2022 (estimated)
- Study completion
- 15 Feb 2023 (estimated)
- First posted
- 7 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity statin monotherapy | Active comparator | Drug: RosuvastatinStatin monotherapy |
| Statin plus ezetimibe combination therapy | Experimental | Drug: Rosuvastatin plus ezetimibeStatin plus ezetimibe combination therapy |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RosuvastatinSubjects will start rosuvastatin 20 mg a day irrespective of previous lipid-lowering treatment or LDL-cholesterol level as current US guideline. | Drug | High-intensity statin monotherapy |
| Rosuvastatin plus ezetimibeSubjects 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. | Drug | Statin plus ezetimibe combination therapy |
Primary outcome
Composite of cardiovascular death
Time frame: Clinical status including medication and clinical events will be evaluated at 2 months.
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.)
Composite of cardiovascular death
Time frame: Clinical status including medication and clinical events will be evaluated at 6 months.
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.)
Composite of cardiovascular death
Time frame: Clinical status including medication and clinical events will be evaluated at every years until 3 years.
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.)
Major cardiovascular event
Time frame: Clinical status including medication and clinical events will be evaluated at 2 months.
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.)
Major cardiovascular event
Time frame: Clinical status including medication and clinical events will be evaluated at 6 months.
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.)
Major cardiovascular event
Time frame: Clinical status including medication and clinical events will be evaluated at every years until 3 years.
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.)
Composite of nonfatal stroke
Time frame: Clinical status including medication and clinical events will be evaluated at 2 months.
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.)
Composite of nonfatal stroke
Time frame: Clinical status including medication and clinical events will be evaluated at 6 months.
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.)
Composite of nonfatal stroke
Time frame: Clinical status including medication and clinical events will be evaluated at every years until 3 years.
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.)
4 secondary outcomes
Clinical efficacy of lipid lowering treatment
Time frame: 3years
Clinical safety of lipid lowering treatment
Time frame: 3years
statin discontinuation and intolerance
Time frame: 3years
Clinical adverse events
Time frame: 3years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Derived from this study: PubMed 39322526Lee JH, Ahn SG, Jeon HS, Lee JW, Youn YJ, Lee YJ, Lee SJ, Hong SJ, Ahn CM, Ko YG, Kim JS, Choi D, Hong MK, Jang Y, Kim BK. Remnant cholesterol as a residual risk in atherosclerotic cardiovascular disease patients under statin-based lipid-lowering therapy: A post hoc analysis of the RACING trial. J Clin Lipidol. 2024 Nov-Dec;18(6):e905-e914. doi: 10.1016/j.jacl.2024.07.005. Epub 2024 Jul 27.
- Derived from this study: PubMed 37978309Kim BG, Lee SJ, Lee YJ, You SC, Hong SJ, Yun KH, Hong BK, Heo JH, Rha SW, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Jang Y, Cho YH, Kim JS. Effect of moderate-intensity statin with ezetimibe combination vs. high-intensity statin therapy according to sex in patients with atherosclerosis. Sci Rep. 2023 Nov 17;13(1):20157. doi: 10.1038/s41598-023-47505-x.
- Derived from this study: PubMed 37531130Lee SJ, Cha JJ, Choi WG, Lee WS, Jeong JO, Choi S, Cho YH, Park W, Yoon CH, Lee YJ, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Jang Y, Hong SJ, Kim JS; RACING Investigators. Moderate-Intensity Statin With Ezetimibe Combination Therapy vs High-Intensity Statin Monotherapy in Patients at Very High Risk of Atherosclerotic Cardiovascular Disease: A Post Hoc Analysis From the RACING Randomized Clinical Trial. JAMA Cardiol. 2023 Sep 1;8(9):853-858. doi: 10.1001/jamacardio.2023.2222.
- Derived from this study: PubMed 37090440Park JI, Lee SJ, Hong BK, Cho YH, Shin WY, Lim SW, Kang WC, Park Y, Lee SY, Lee YJ, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Jang Y, Kim JS; RACING investigators. Efficacy and safety of moderate-intensity statin with ezetimibe combination therapy in patients after percutaneous coronary intervention: a post-hoc analysis of the RACING trial. EClinicalMedicine. 2023 Apr 4;58:101933. doi: 10.1016/j.eclinm.2023.101933. eCollection 2023 Apr.
- Derived from this study: PubMed 37019580Lee SH, Lee YJ, Heo JH, Hur SH, Choi HH, Kim KJ, Kim JH, Park KH, Lee JH, Choi YJ, Lee SJ, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Jang Y, Kim JS. Combination Moderate-Intensity Statin and Ezetimibe Therapy for Elderly Patients With Atherosclerosis. J Am Coll Cardiol. 2023 Apr 11;81(14):1339-1349. doi: 10.1016/j.jacc.2023.02.007.
- Derived from this study: PubMed 36529993Lee YJ, Cho JY, You SC, Lee YH, Yun KH, Cho YH, Shin WY, Im SW, Kang WC, Park Y, Lee SY, Lee SJ, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Jang Y, Kim JS. Moderate-intensity statin with ezetimibe vs. high-intensity statin in patients with diabetes and atherosclerotic cardiovascular disease in the RACING trial. Eur Heart J. 2023 Mar 14;44(11):972-983. doi: 10.1093/eurheartj/ehac709.
- Derived from this study: PubMed 35863366Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rosuvastatin and Rosuvastatin plus ezetimibe in people with Cardiovascular Diseases and Cerebrovascular Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang-Soo Jang, MD, PhD (82-02-2228-8460, jangys1212@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of cardiovascular death (time frame: Clinical status including medication and clinical events will be evaluated at 2 months.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03044665, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019; AzTrials last refreshed its copy on 7 Nov 2026.