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

Coronary Artery Diseasse Clinical Trial

— LODESTAR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02579499
• Other study ID #: 4-2015-0713
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: September 9, 2016
• Est. completion date: November 2022

Study information

• Verified date: November 2022
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4400
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Diseasse
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• 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.
• targeted LDL-C goal statin
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)

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac and cerebrovascular events (MACCE)		3 years
Secondary	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