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

Sponsor

Yonsei University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02579499

Collaborator

(none)

4,400

Enrollment

Location

Arms

Anticipated Duration (Months)

51.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Diseasse	Drug: fixed high potent statin therapy Drug: targeted LDL-C goal statin	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

4400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 1, 2015

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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.
Experimental: Targeted LDL-C goal statin group Patients will be tiltrated statin intensity guided by follow-up LDL-C level	Drug: 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)

Arm

Intervention/Treatment

Active Comparator: 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.

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.

Experimental: Targeted LDL-C goal statin group

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

Drug: 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)

Outcome Measures

Primary Outcome Measures

Major adverse cardiac and cerebrovascular events (MACCE) [3 years]

Secondary Outcome Measures

numer of other adverse clinical events [3 years]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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