Coronary Artery DiseassePhase 4LODESTARNCT02579499

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

A Phase 4 study testing fixed high potent statin therapy and targeted LDL-C goal statin in people with Coronary Artery Diseasse, run by Yonsei University at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 19 years and older
Conditions the study is for: Coronary Artery Diseasse
What is being tested?: fixed high potent statin therapy and targeted LDL-C goal statin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4,400 participants
Where: 1 siteSouth Korea
Study dates: 9 Sep 2016to Nov 2022
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

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

Other trials in South Korea

About this study

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

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).

Conditions: Coronary Artery Diseasse
Being tested: fixed high potent statin therapy, targeted LDL-C goal statin
Keywords: Coronary artery disease, LDL choelsterol, Statin
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

fixed high potent statin therapyDrug
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 statinDrug
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)

Study groups in NCT02579499
Study group	Role	What they receive
Fixed high-potent statin group	Active comparator	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. Receives: Drug: fixed high potent statin therapy
Targeted LDL-C goal statin group	Experimental	Patients will be tiltrated statin intensity guided by follow-up LDL-C level Receives: Drug: targeted LDL-C goal statin

What is being measured

The primary outcome is the main question the study is designed to answer.

Major adverse cardiac and cerebrovascular events (MACCE)
Measured: 3 years

Secondary outcomes (1)

numer of other adverse clinical events
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)
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Sep 2016Nov 2022

First posted19 Oct 2015 (estimated)
Study start9 Sep 2016
Primary completionNov 2022 (estimated)
Study completionNov 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseasseStudies of the same condition, open and under way.
More trials run by Yonsei UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 4,400 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02579499
Sponsor's protocol ID: 4-2015-0713
Acronym: LODESTAR
Status last verified: Nov 2022
First submitted: 15 Oct 2015
Last updated: 30 Nov 2022
Results posted: No
Data monitoring committee: Yes

Publications

Hong SJ, Lee YJ, Kang WC, Hong BK, Lee JY, Lee JB, Yang TH, Yoon J, Lee SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Hong MK; LODESTAR investigators. Effect of rosuvastatin versus atorvastatin on new-onset diabetes mellitus in patients treated with high-intensity statin therapy for coronary artery disease: a post-hoc analysis from the LODESTAR randomized clinical trial. Cardiovasc Diabetol. 2024 Aug 7;23(1):287. doi: 10.1186/s12933-024-02386-w.
PubMed 39113067
Lee SJ, Lee JB, Yang TH, Kang WC, Lee JY, Lee YJ, Hong SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Hong BK, Choi D, Yoon J, Jang Y, Hong MK; LODESTAR investigators. Treat-to-target or high-intensity statin treatment in older adults with coronary artery disease: a post hoc analysis of the LODESTAR trial. Age Ageing. 2024 Jul 2;53(7):afae132. doi: 10.1093/ageing/afae132.
PubMed 38965031
Lee YJ, Hong SJ, Kang WC, Hong BK, Lee JY, Lee JB, Cho HJ, Yoon J, Lee SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Hong MK; LODESTAR investigators. Rosuvastatin versus atorvastatin treatment in adults with coronary artery disease: secondary analysis of the randomised LODESTAR trial. BMJ. 2023 Oct 18;383:e075837. doi: 10.1136/bmj-2023-075837.
PubMed 37852649
Lee SJ, Kang WC, Lee JY, Lee JB, Yang TH, Yoon J, Lee YJ, Hong SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Hong BK, Jang Y, Hong MK; LODESTAR Investigators. Treat-to-target versus high-intensity statin treatment in patients with or without diabetes mellitus: a pre-specified analysis from the LODESTAR trial. EClinicalMedicine. 2023 Sep 20;64:102227. doi: 10.1016/j.eclinm.2023.102227. eCollection 2023 Oct.
PubMed 37767195
Hong SJ, Lee YJ, Lee SJ, Hong BK, Kang WC, Lee JY, Lee JB, Yang TH, Yoon J, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Hong MK; LODESTAR Investigators. Treat-to-Target or High-Intensity Statin in Patients With Coronary Artery Disease: A Randomized Clinical Trial. JAMA. 2023 Apr 4;329(13):1078-1087. doi: 10.1001/jama.2023.2487.
PubMed 36877807

Study at a glance

From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02579499
Acronym / sponsor ID: LODESTAR / 4-2015-0713
Conditions: Coronary Artery Diseasse
Keywords: Coronary artery disease, LDL choelsterol, Statin
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 4,400 participants (actual)
Lead sponsor: Yonsei UniversityUniversity, hospital or other
Study start: 9 Sep 2016 (actual)
Primary completion: Nov 2022 (estimated)
Study completion: Nov 2022 (estimated)
First posted: 19 Oct 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Fixed high-potent statin group	Active comparator	Drug: fixed high potent statin therapyAccording 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.
Targeted LDL-C goal statin group	Experimental	Drug: targeted LDL-C goal statinPatients will be tiltrated statin intensity guided by follow-up LDL-C level

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
fixed high potent statin therapyPatients 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.	Drug	Fixed high-potent statin group
targeted LDL-C goal statin1. 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)	Drug	Targeted LDL-C goal statin group

Primary outcome

Major adverse cardiac and cerebrovascular events (MACCE)
Time frame: 3 years

1 secondary outcome

numer of other adverse clinical events
Time frame: 3 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
Derived from this study: PubMed 39113067Hong SJ, Lee YJ, Kang WC, Hong BK, Lee JY, Lee JB, Yang TH, Yoon J, Lee SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Hong MK; LODESTAR investigators. Effect of rosuvastatin versus atorvastatin on new-onset diabetes mellitus in patients treated with high-intensity statin therapy for coronary artery disease: a post-hoc analysis from the LODESTAR randomized clinical trial. Cardiovasc Diabetol. 2024 Aug 7;23(1):287. doi: 10.1186/s12933-024-02386-w.
Derived from this study: PubMed 38965031Lee SJ, Lee JB, Yang TH, Kang WC, Lee JY, Lee YJ, Hong SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Hong BK, Choi D, Yoon J, Jang Y, Hong MK; LODESTAR investigators. Treat-to-target or high-intensity statin treatment in older adults with coronary artery disease: a post hoc analysis of the LODESTAR trial. Age Ageing. 2024 Jul 2;53(7):afae132. doi: 10.1093/ageing/afae132.
Derived from this study: PubMed 37852649Lee YJ, Hong SJ, Kang WC, Hong BK, Lee JY, Lee JB, Cho HJ, Yoon J, Lee SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Hong MK; LODESTAR investigators. Rosuvastatin versus atorvastatin treatment in adults with coronary artery disease: secondary analysis of the randomised LODESTAR trial. BMJ. 2023 Oct 18;383:e075837. doi: 10.1136/bmj-2023-075837.
Derived from this study: PubMed 37767195Lee SJ, Kang WC, Lee JY, Lee JB, Yang TH, Yoon J, Lee YJ, Hong SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Hong BK, Jang Y, Hong MK; LODESTAR Investigators. Treat-to-target versus high-intensity statin treatment in patients with or without diabetes mellitus: a pre-specified analysis from the LODESTAR trial. EClinicalMedicine. 2023 Sep 20;64:102227. doi: 10.1016/j.eclinm.2023.102227. eCollection 2023 Oct.
Derived from this study: PubMed 36877807Hong SJ, Lee YJ, Lee SJ, Hong BK, Kang WC, Lee JY, Lee JB, Yang TH, Yoon J, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Hong MK; LODESTAR Investigators. Treat-to-Target or High-Intensity Statin in Patients With Coronary Artery Disease: A Randomized Clinical Trial. JAMA. 2023 Apr 4;329(13):1078-1087. doi: 10.1001/jama.2023.2487.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MYEONG-KI HONG, MD, PhD principal investigator

Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing fixed high potent statin therapy and targeted LDL-C goal statin in people with Coronary Artery Diseasse, run by Yonsei University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major adverse cardiac and cerebrovascular events (MACCE) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02579499, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.