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

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ClinicalTrials.gov Identifier: NCT02579499
Recruitment Status : Recruiting
First Posted : October 19, 2015
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
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).

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : October 2015
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


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
  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)




Primary Outcome Measures :
  1. Major adverse cardiac and cerebrovascular events (MACCE) [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. numer of other adverse clinical events [ Time Frame: 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



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02579499


Locations
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Korea, Republic of
Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: MYEONG-KI HONG, MD, Ph.D    82-2-2228-8460    MKHONG61@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02579499     History of Changes
Other Study ID Numbers: 4-2015-0713
First Posted: October 19, 2015    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Keywords provided by Yonsei University:
Coronary artery disease
LDL choelsterol
Statin
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Atorvastatin
Rosuvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors