NCT06338956

Brief 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. However, the European guideline recommends less than 55 mg/dL of LDL-C after PCI.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135,877

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2025

Completed
Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

1 year

First QC Date

March 24, 2024

Last Update Submit

May 17, 2025

Conditions

Coronary Artery DiseaseHyperlipidemias

Keywords

Percutaneous coronary interventionStatin

Outcome Measures

Primary Outcomes (1)

  • MACCE

    major adverse cardiac and cerebrovascular events

    10 years after PCI

Secondary Outcomes (4)

  • Cardiovascular death

    10 years after PCI

  • Spontaneous myocardial infarction

    10 years after PCI

  • Repeat revascularization

    10 years after PCI

  • Ischemic stroke

    10 years after PCI

Study Arms (2)

>=50% LDL-C reduction

LDL-C reduction \>=50% Further divided by LDL \<55mg/dL 55\< LDL \< 70 mg/dL LDL \> 70 mg/dL

Drug: LDL reduction therapy

<50% LDL-C reduction

LDL-C reduction \<50%

Drug: LDL reduction therapy

Interventions

LDL reduction therapyDRUG

LDL reduction therapy

<50% LDL-C reduction>=50% LDL-C reduction

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with coronary artery disease undergoing PCI

You may qualify if:

  • Patients receiving PCI with health check up before and after PCI within 3 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 40294950DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseHyperlipidemias

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 24, 2024

First Posted

April 1, 2024

Study Start

January 1, 2024

Primary Completion

December 31, 2024

Study Completion

May 15, 2025

Last Updated

May 21, 2025

Record last verified: 2025-05

Locations

KR(1)