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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

4400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-09

Study Completion Date

2022-11-30

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).

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Detailed Description

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Conditions

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Coronary Artery Diseasse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fixed high-potent statin group

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.

Group Type ACTIVE_COMPARATOR

fixed high potent statin therapy

Intervention Type DRUG

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.

Targeted LDL-C goal statin group

Patients will be tiltrated statin intensity guided by follow-up LDL-C level

Group Type EXPERIMENTAL

targeted LDL-C goal statin

Intervention Type DRUG

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)

Interventions

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fixed high potent statin therapy

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.

Intervention Type DRUG

targeted LDL-C goal statin

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)

Intervention Type DRUG

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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No