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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-intensity statin monotherapy | Active Comparator | Statin monotherapy |
|
| Statin plus ezetimibe combination therapy | Experimental | Statin plus ezetimibe combination therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | Subjects will start rosuvastatin 20 mg a day irrespective of previous lipid-lowering treatment or LDL-cholesterol level as current US guideline. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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.) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical efficacy of lipid lowering treatment |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang-Soo Jang, MD, PhD | Contact | 82-02-2228-8460 | jangys1212@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine | Recruiting | Seoul | 03722 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39322526 | Derived | 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. | |
| 37978309 |
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| Rosuvastatin plus ezetimibe | Drug | 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. |
|
| 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.) | 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.) | 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.) | 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.) | Clinical status including medication and clinical events will be evaluated at every years until 3 years. |
| 3years |
| Clinical safety of lipid lowering treatment |
| 3years |
| statin discontinuation and intolerance |
| 3years |
| Clinical adverse events |
| 3years |
| Derived |
| Kim 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. |
| 37531130 | Derived | Lee 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. |
| 37090440 | Derived | Park 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. |
| 37019580 | Derived | Lee 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. |
| 36529993 | Derived | Lee 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. |
| 35863366 | Derived | 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. |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D002561 | Cerebrovascular Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001384 | Azetidines |
| D001385 | Azetines |
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