Coronary Artery DiseaseLipid-PCINCT06338956
Optimal Attained LDL-Cholesterol Levels in Patients Who Achieved ≥50% LDL Reduction After PCI
An observational study of Coronary Artery Disease and Hyperlipidemias, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
For the management of low-density lipoprotein-cholesterol (LDL-C), some guidelines recommend initial statin treatment with high-intensity statins to achieve at least a 50% reduction in LDL-C levels. High-intensity or maximally tolerated intensity can be maintained without a target goal. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease, Hyperlipidemias
- What is being tested?
- LDL reduction therapy
- How many people
- 135,877 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2024to 15 May 2025
- Phase
- Observational
- 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
Study population: Patients with coronary artery disease undergoing PCI
Who may be able to join
- Patients receiving PCI with health check up before and after PCI within 3 years
Who cannot join
- Patients receiving statin before PCI
- Patients with liver cirrhosis
- Patients with cancer
- Patients without prescription of statin
- Patients with LDL-C <55 mg/dL before PCI
Trial locations and contacts
1 site in 1 country.
About this study
For the management of low-density lipoprotein-cholesterol (LDL-C), some guidelines recommend initial statin treatment with high-intensity statins to achieve at least a 50% reduction in LDL-C levels. High-intensity or maximally tolerated intensity can be maintained without a target goal. However, the European guideline recommends less than 55 mg/dL of LDL-C after PCI.
Read the detailed description
To investigate the Optimal Attained LDL-C Levels in Patients Who Achieved ≥50% LDL-C Reduction After PCI.
- Conditions
- Coronary Artery Disease, Hyperlipidemias
- Being tested
- LDL reduction therapy
- Keywords
- Percutaneous coronary intervention, Statin
- Medical subject headings
- Coronary Artery Disease, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LDL reduction therapyDrug
LDL reduction therapy
| Study group | Role | What they receive |
|---|---|---|
| >=50% LDL-C reduction | LDL-C reduction >=50%
Further divided by LDL <55mg/dL 55< LDL < 70 mg/dL LDL > 70 mg/dL Receives: Drug: LDL reduction therapy | |
| <50% LDL-C reduction | LDL-C reduction <50% Receives: Drug: LDL reduction therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACCE
major adverse cardiac and cerebrovascular events
Measured: 10 years after PCI
Secondary outcomes (4)
Cardiovascular death
death from cardiovascular cause
Measured: 10 years after PCI
Spontaneous myocardial infarction
MI with hospitalziation
Measured: 10 years after PCI
Repeat revascularization
additional PCI or CABG
Measured: 10 years after PCI
Ischemic stroke
Stoke from ischemic cause
Measured: 10 years after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2024
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 135,877 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ki Hong Choi, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338956
- Sponsor's protocol ID
- Lipid-PCI
- Acronym
- Lipid-PCI
- Status last verified
- May 2025
- First submitted
- 24 Mar 2024
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kang D, Choi KH, Yang S, Kim H, Park TK, Lee JM, Cho J, Yang JH, Song YB, Choi SH, Gwon HC, Hahn JY. Clinical significance of low-density lipoprotein cholesterol percentage reduction and attained levels after percutaneous coronary intervention. CMAJ. 2025 Apr 27;197(16):E442-E452. doi: 10.1503/cmaj.241713.
PubMed 40294950
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Attained LDL-Cholesterol Levels in Patients Who Achieved ≥50% LDL Reduction After PCI
- ClinicalTrials.gov ID
- NCT06338956
- Acronym / sponsor ID
- Lipid-PCI / Lipid-PCI
- Conditions
- Coronary Artery Disease, Hyperlipidemias
- Keywords
- Percutaneous coronary intervention, Statin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135,877 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 1 Apr 2024 (actual)
- 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.
For the management of low-density lipoprotein-cholesterol (LDL-C), some guidelines recommend initial statin treatment with high-intensity statins to achieve at least a 50% reduction in LDL-C levels. High-intensity or maximally tolerated intensity can be maintained without a target goal. However, the European guideline recommends less than 55 mg/dL of LDL-C after PCI.
Detailed description
To investigate the Optimal Attained LDL-C Levels in Patients Who Achieved ≥50% LDL-C Reduction After PCI.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| >=50% LDL-C reduction | – | Drug: LDL reduction therapyLDL-C reduction >=50% Further divided by LDL <55mg/dL 55< LDL < 70 mg/dL LDL > 70 mg/dL |
| <50% LDL-C reduction | – | Drug: LDL reduction therapyLDL-C reduction <50% |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary artery disease undergoing PCI
Key inclusion criteria (1 listed)
- Patients receiving PCI with health check up before and after PCI within 3 years
Key exclusion criteria (5 listed)
- Patients receiving statin before PCI
- Patients with liver cirrhosis
- Patients with cancer
- Patients without prescription of statin
- Patients with LDL-C <55 mg/dL before PCI
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 |
|---|---|---|
| LDL reduction therapyLDL reduction therapy | Drug | <50% LDL-C reduction, >=50% LDL-C reduction |
Primary outcome
MACCE
Time frame: 10 years after PCI
major adverse cardiac and cerebrovascular events
4 secondary outcomes
Cardiovascular death
Time frame: 10 years after PCI
Spontaneous myocardial infarction
Time frame: 10 years after PCI
Repeat revascularization
Time frame: 10 years after PCI
Ischemic stroke
Time frame: 10 years after PCI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Derived from this study: PubMed 40294950Kang D, Choi KH, Yang S, Kim H, Park TK, Lee JM, Cho J, Yang JH, Song YB, Choi SH, Gwon HC, Hahn JY. Clinical significance of low-density lipoprotein cholesterol percentage reduction and attained levels after percutaneous coronary intervention. CMAJ. 2025 Apr 27;197(16):E442-E452. doi: 10.1503/cmaj.241713.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Hyperlipidemias, run by Samsung Medical Center 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 21 May 2025. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
MACCE (time frame: 10 years after PCI). 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 NCT06338956, which also lists 1 linked publication.
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 21 May 2025.