Low-Density Lipoprotein Cholesterol-targeting Statin Therapy Versus the Intensity-based Statin Therapy in Patients With Coronary Artery Disease

Yonsei University4,400 enrolled

Overview

To compare clinical safety \& efficacy of fixed-high potent statin therapy (according to 2013 ACC/AHA guideline) vs. targeted LDL-C goal statin therapy (LDL\<70mg/dL) for secondary prevention. Total 4400 patients with coronary artery disease patients requiring statin treatment were categorized fixed high-potent statin group and targeted LDL-C group. The investigators will compare primary endpoint (major adverse cardiac and cerebrovascular event (MACCE)) and secondary endpoint (1. New onset diabetes mellitus after randomization, 2. Hospitalization due to heart failure, 3. Deep vein thrombosis or Pulmonary thromboembolism, 4. Percutaneous trans-luminal angioplasty on peripheral artery obstructive disease, 5. Aortic intervention or operation, 6. ESRD with renal replacement therapy).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

4,400

Conditions

Coronary Artery Diseasse

Interventions

targeted LDL-C goal statinDRUG

1. Statin naïve patients: Patients will be received moderate intensity statin therapy (atorvastatin 20mg or rosuvastatin 10mg) 2. Patients already received statin therapy * Baseline LDL-C \<70mg: same intensity of statin therapy * Baseline LDL-C≥70mg: uptiltrated statin therapy Patients will be tiltrated statin intensity guided by follow-up LDL-C level ( Attained LDL-C \< 50mg/dL : down regulated intensity statin therapy, 50mg/dL ≤ Attained LDL-C \< 70g/dL: maintain current intensity statin therapy, Attained LDL-C ≥ 70mg/dL: up regulated intensity statin therapy)

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients ≥ 19 years old * Patients clinically diagnosed with coronary artery disease including stable angina, unstable angina, acute non-ST elevation myocardial infarction and acute ST elevation myocardial infarction * Patients with signed informed consent Exclusion Criteria: * Pregnant women or women with potential childbearing * Patients severe adverse events or hypersensitive to statin or patients with multi-drug allergy. * Who had received drug that have a drug interaction with statin (strong inhibitor of cytochrome p-450 3A4 or 2C9) * Patients with risk factors for myopathy with hereditary muscle disorder, hypothyroidism, alcohol use disorder, severe hepatic dysfunction (3 times normal reference values) or rhabdomyolysis * Life expectancy \< 3 years * Patient with who can not be followed up for more than 1 year * Patients who cannot understand or read the consent form

Outcomes

Primary Outcomes

Major adverse cardiac and cerebrovascular events (MACCE)

Time frame: 3 years

Secondary Outcomes

numer of other adverse clinical events

1. New onset diabetes mellitus after randomization 2. Hospitalization due to heart failure 3. Deep vein thrombosis or Pulmonary thromboembolism 4. Percutaneous trans-luminal angioplasty on peripheral artery obstructive disease 5. Aortic intervention or operation 6. ESRD with renal replacement therapy 7. Discontinuation of study drugs due to intolerance 8. Cataract operation 9. Composite of laboratory abnormality (ALT \>3x ULN, CK \>5x ULN, or elevation in creatinine)