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

Phase 4

Active, not recruiting

• Conditions: Coronary Artery Diseasse
• Interventions: Drug: fixed high potent statin therapy; Drug: targeted LDL-C goal statin

• Registration Number: NCT02579499
• Lead Sponsor: Yonsei University

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-15
• Study First Submitted QC: 2015-10-16
• Study First Posted: 2015-10-19
• Study Start: 2016-09-09
• Status Verified: 2022-11
• Primary Completion: 2022-11
• Study Completion: 2022-11
• Last Update Submitted: 2022-11-28
• Last Update Posted: 2022-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 4400

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fixed high-potent statin group	fixed high potent statin therapy	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.
Targeted LDL-C goal statin group	targeted LDL-C goal statin	Patients will be tiltrated statin intensity guided by follow-up LDL-C level

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac and cerebrovascular events (MACCE)	3 years

Secondary Outcome Measures

Name	Time	Method
numer of other adverse clinical events	3 years	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)

Trial Locations

Locations (1)

Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of