Back to resultsLow-Density Lipoprotein Cholesterol-targeting Statin Therapy Versus the Intensity-based Statin Therapy in Patients With Coronary Artery Disease (LODESTAR)
Primary Purpose
Coronary Artery Diseasse
Status
Active
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
fixed high potent statin therapy
targeted LDL-C goal statin
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Diseasse focused on measuring Coronary artery disease, LDL choelsterol, Statin
Eligibility Criteria
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
Sites / Locations
- Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Fixed high-potent statin group
Targeted LDL-C goal statin group
Arm Description
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.
Patients will be tiltrated statin intensity guided by follow-up LDL-C level
Outcomes
Primary Outcome Measures
Major adverse cardiac and cerebrovascular events (MACCE)
Secondary Outcome Measures
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02579499
Brief Title
Low-Density Lipoprotein Cholesterol-targeting Statin Therapy Versus the Intensity-based Statin Therapy in Patients With Coronary Artery Disease
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 9, 2016 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
Yes
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Diseasse
Keywords
Coronary artery disease, LDL choelsterol, Statin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fixed high-potent statin group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Targeted LDL-C goal statin group
Arm Type
Experimental
Arm Description
Patients will be tiltrated statin intensity guided by follow-up LDL-C level
Intervention Type
Drug
Intervention Name(s)
fixed high potent statin therapy
Intervention Description
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
Intervention Name(s)
targeted LDL-C goal statin
Intervention Description
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)
Primary Outcome Measure Information:
Title
Major adverse cardiac and cerebrovascular events (MACCE)
Time Frame
3 years
Secondary Outcome Measure Information:
Title
numer of other adverse clinical events
Description
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)
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MYEONG-KI HONG, MD, PhD
Organizational Affiliation
Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Low-Density Lipoprotein Cholesterol-targeting Statin Therapy Versus the Intensity-based Statin Therapy in Patients With Coronary Artery Disease
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