MedTrace Logo

Optimal LDL-C Target in High-risk Patients After PCI

NCT06821711 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12000

Last updated 2025-02-19

No results posted yet for this study

Summary

Extensive evidence from epidemiological, genetic, and randomized controlled trials (RCTs) of lipid-lowering therapies has firmly established a causal relationship between low-density lipoprotein cholesterol (LDL-C) and atherosclerotic cardiovascular disease (ASCVD), establishing LDL-C as both a pathogenic risk factor and a critical therapeutic target.

Lipid-lowering therapies targeting LDL-C have significantly decreased the overall risk in ASCVD patients. Consequently, current guidelines recommend, based on risk stratification, lowering LDL-C levels in high-risk ASCVD patients to \<1.4 mmol/L with a ≥50% reduction from baseline. Findings from PROVE IT-TIMI 22, IMPROVE-IT, ODYSSEY OUTCOMES, and FOURIER-OLE trials suggest that achieving extremely low LDL-C levels may further reduce the risk of cardiovascular events in ASCVD patients without substantially increasing clinically relevant adverse events; however, randomized data was still scarce in supporting this notion.

Against these backgrounds, we have designed this trial to investigate whether targeting LDL-C levels \<0.8 mmol/L in high-risk ASCVD patients results in a significant reduction in adverse events compared to targeting LDL-C levels of 0.8-1.4 mmol/L.

Conditions

  • Chronic Coronary Syndrome
  • Acute Coronary Syndromes
  • Percutaneous Coronary Intervention
  • High Risk Patient

Interventions

OTHER

Intensive LDL-C control

By Statin, Ezetimibe, or PCSK9i, prescribed according to LDL-C level at baseline and follow-up; For patients with baseline LDL-C level \< 3.0 mmol/L, it is recommended to start lipid control by statin + PCSK9i; for LDL-C level ≥ 3.0 mmol/L, statin + ezetimibe + PCSK9i

OTHER

Conventional LDL-C control

By Statin, Ezetimibe, or PCSK9i, prescribed according to LDL-C level at baseline and follow-up; For patients with baseline LDL-C level \< 3.0 mmol/L, it is recommended to start lipid control by statin alone or statin + ezetimibe; for LDL-C level ≥ 3.0 mmol/L, statin + PCSK9i

Sponsors & Collaborators

  • Xijing Hospital

    lead OTHER

Principal Investigators

  • Ling Tao, Ph.D., M.D. · Department of Cardiology, Xijing Hospital

  • Chao Gao, Ph.D., M.D. · Department of Cardiology, Xijing Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-20
Primary Completion
2029-08-15
Completion
2029-08-15

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06821711 on ClinicalTrials.gov