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

Study Overview
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Brief Summary
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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).

Official Title
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Low-Density Lipoprotein Cholesterol-targeting Statin Therapy Versus the Intensity-based Statin Therapy in Patients With Coronary Artery Disease: a Randomized Comparison Trial

Conditions
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Coronary Artery Diseasse

Intervention / Treatment
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* Drug: fixed high potent statin therapy
* Drug: targeted LDL-C goal statin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fixed high-potent statin group<br>According to 2013 ACC/AHA guideline, patients will be received high-intensity statin therapy (atorvastatin 40mg or rosuvastatin 20mg) regardless of their baseline LDL-C levels. | Drug: fixed high potent statin therapy<br>* Patients assigned fixed high-potent statin group will be received high-intensity statin therapy (atorvastatin 40mg or rosuvastatin 20mg) regardless of their baseline LDL-C levels, and maintain high-intensity statin therapy regardless of their follow-up LDL-C level.<br>|
| Experimental: Targeted LDL-C goal statin group<br>Patients will be tiltrated statin intensity guided by follow-up LDL-C level | Drug: targeted LDL-C goal statin<br>* Statin naïve patients: Patients will be received moderate intensity statin therapy (atorvastatin 20mg or rosuvastatin 10mg) 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac and cerebrovascular events (MACCE) |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| numer of other adverse clinical events | New onset diabetes mellitus after randomization Hospitalization due to heart failure Deep vein thrombosis or Pulmonary thromboembolism Percutaneous trans-luminal angioplasty on peripheral artery obstructive disease Aortic intervention or operation ESRD with renal replacement therapy Discontinuation of study drugs due to intolerance Cataract operation Composite of laboratory abnormality (ALT >3x ULN, CK >5x ULN, or elevation in creatinine) | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery disease, LDL choelsterol, Statin