Effect of Intensive LDL-cholesterol Targeting for Elderly Patients With Cardiovascular Disease: I-OLD Trial

Cardiovascular death

Occurrence of cardiovascular death during the 3-year follow-up period

Time frame: 3 years

Non-fatal MI

Occurrence of non-fatal MI during the 3-year follow-up period

Time frame: 3 years

Non-fatal stroke

Occurrence of non-fatal stroke during the 3-year follow-up period

Time frame: 3 years

Coronary revascularization

Occurrence of coronary revascularization during the 3-year follow-up period

Time frame: 3 years

Hospitalization for unstable angina

Occurrence of hospitalization for unstable angina during the 3-year follow-up period

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 3 years

New-onset diabetes mellitus

Occurrence of new-onset diabetes mellitus during the 3-year follow-up period

Time frame: 3 years

Worsening of glycemic control

Occurrence of worsening of glycemic control during the 3-year follow-up period

Time frame: 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

Time frame: 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

Time frame: 3 years

Elevation of muscle enzymes

Occurrence of elevation of muscle enzymes (CPK level \> 4 x UNL) during the 3-year follow-up period

Time frame: 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

Time frame: 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

Time frame: 3 years

Change of proteinuria

Change in proteinuria assessed by urinalysis from baseline at 1, 2, and 3 years after enrollment

Time frame: 3 years

Diagnosis of cancer

Occurrence of diagnosis of cancer during the 3-year follow-up period

Time frame: 3 years

Operation due to cataract

Occurrence of operation due to cataract during the 3-year follow-up period

Time frame: 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

Time frame: 3 years