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

November 28, 2022 updated by: Yonsei University

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Major adverse cardiac and cerebrovascular events (MACCE)
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
  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)
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: MYEONG-KI HONG, MD, PhD, Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2016

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

October 15, 2015

First Submitted That Met QC Criteria

October 16, 2015

First Posted (Estimate)

October 19, 2015

Study Record Updates

Last Update Posted (Actual)

November 30, 2022

Last Update Submitted That Met QC Criteria

November 28, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2015-0713

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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