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Although there have been studies regarding intensive lowering of low-density lipoprotein (LDL)-cholesterol with high intensity statins in patients with cardiovascular disease, elderly patients were either excluded or accounted only a small portion of study subjects. Therefore, this study sought to compare the clinical outcomes according to the LDL-cholesterol therapy strategy (intensive targeting [LDL-cholesterol goal of <55mg/dL] vs. conventional therapy [moderate intensity statin therapy]) in elderly patients with ≥75 years and documented cardiovascular disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive targeting group | Experimental | Intensive lipid loweroing therapy with LDL-cholesterol goal of <55mg/dL |
|
| Conventional therapy group | Active Comparator | Initiate and maintain moderate intensity statin therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive targeting group | Drug | Intensive lipid lowering therapy with LDL-cholesterol goal of <55mg/dL. Atorvastatin 5, 10, 20, 40, and 80mg are allowed to use and ezetimibe or PCSK-9 inhibitor may be considered in patients who could not achieve target LDL-cholesterol level even with the maximum dose of study drugs (atorvastatin 80mg) by the discretion of the investigator. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical efficacy of intensive lipid-lowering therapy | Primary Outcome - Composite of cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, coronary revascularization, and hospitalization for unstable angina | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular death | Occurrence of cardiovascular death during the 3-year follow-up period | 3 years |
| Non-fatal MI | Occurrence of non-fatal MI during the 3-year follow-up period |
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Inclusion criteria
Exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Health System, Severance Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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|
| Conventional therapy group | Drug | Only moderate intensity statin therapy (atorvastatin 5, 10, and 20mg ) are allowed. Ezetimibe or PCSK-9 inhibitor is not allowed to use. |
|
| 3 years |
| Non-fatal stroke | Occurrence of non-fatal stroke during the 3-year follow-up period | 3 years |
| Coronary revascularization | Occurrence of coronary revascularization during the 3-year follow-up period | 3 years |
| Hospitalization for unstable angina | Occurrence of hospitalization for unstable angina during the 3-year follow-up period | 3 years |
| Composite of cardiovascular death, non-fatal MI, and non-fatal stroke | First occurrence of cardiovascular death, non-fatal MI, or non-fatal stroke during the 3-year follow-up period | 3 years |
| Composite of cardiovascular death, non-fatal MI, non-fatal stroke, and coronary revascularization | First occurrence of cardiovascular death, non-fatal MI, non-fatal stroke, or coronary revascularization during the 3-year follow-up period | 3 years |
| Composite of cardiovascular death, non-fatal MI, and coronary revascularization | First occurrence of cardiovascular death, non-fatal MI, or coronary revascularization during the 3-year follow-up period | 3 years |
| Composite of all-cause death, non-fatal MI, non-fatal stroke, coronary revascularization, and hospitalization for unstable angina | First occurrence of all-cause death, non-fatal MI, non-fatal stroke, coronary revascularization, or hospitalization for unstable angina during the 3-year follow-up period | 3 years |
| Rate of cross-over into the non-allocated therapy strategy | Rate of cross-over into the non-allocated therapy strategy at 1 month, and 1, 2, and 3 years after enrollment | 3 years |
| New-onset diabetes mellitus | Occurrence of new-onset diabetes mellitus during the 3-year follow-up period | 3 years |
| Worsening of glycemic control | Occurrence of worsening of glycemic control during the 3-year follow-up period | 3 years |
| Change of homeostasis model assessment of insulin resistance (HOMA-IR) index | Change in HOMA-IR index from baseline at 1, 2, and 3 years after enrollment | 3 years |
| Occurrence of statin-associated muscle symptoms (SAMS) requiring change of therapy regimen or dosage | Occurrence of SAMS requiring change of therapy regimen or dosage during the 3-year follow-up period | 3 years |
| Elevation of muscle enzymes | Occurrence of elevation of muscle enzymes (CPK level > 4 x UNL) during the 3-year follow-up period | 3 years |
| Elevation of hepatic enzymes | Occurrence of elevation of hepatic enzymes (AST, ALT, or both levels ≥ 3 x UNL) during the 3-year follow-up period | 3 years |
| Elevation of serum creatinine level | Occurrence of elevation of serum creatinine level (>50% increase from baseline) during the 3-year follow-up period | 3 years |
| Change of proteinuria | Change in proteinuria assessed by urinalysis from baseline at 1, 2, and 3 years after enrollment | 3 years |
| Diagnosis of cancer | Occurrence of diagnosis of cancer during the 3-year follow-up period | 3 years |
| Operation due to cataract | Occurrence of operation due to cataract during the 3-year follow-up period | 3 years |
| Major bleeding (BARC 2, 3, or 5) | Occurrence of major bleeding (BARC 2, 3, or 5) during the 3-year follow-up period | 3 years |