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NCT06821711

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

Sponsor: Xijing Hospital

View on ClinicalTrials.gov

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.

Official title: Targeting LDL-C to Less Than 0.8 mmol/L in Patients After PCI With High Risk of Cardiovascular Disease: an Open-label, Assessor-blinded, Randomized Trial (REC-SAFETARGET Trial)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

12000

Start Date

2025-02-20

Completion Date

2029-08-15

Last Updated

2025-02-19

Healthy Volunteers

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

Inclusion Criteria: 1. Patients underwent percutaneous coronary intervention due to acute or chronic coronary syndrome 2. Patients with ASCVD at extremely high risk 3. Patients who are able to complete the follow-up and compliant with the allocated treatment * ASCVD at extremely high risk is defined as fulfilling at least TWO of the following criteria: 1. PCI for acute myocardial infarction (AMI, including STEMI or NSTEMI) 2. Previous AMI, previous stroke, or previous intervention or surgery for peripheral vascular disease 3. Experienced cardiovascular event(s) with LDL-C≤1.8mmol/L 4. LDL-C≥4.9mmol/L 5. Diabetes 6. CKD (eGFR \< 60 ml/min/1.73m2) 7. Current smoking 8. Recurrent cardio/cerebrovascular events 9. History of premature ASCVD (\< 55 male, \< 65 female) 10. Complex PCI (fulfilling at least one of the following criteria: multivessel disease; in-stent restenosis; ≥ 3 stents implanted; total stent length ≥ 60 mm; bifurcation; left main disease; target lesions allocated in bypass graft; chronic total occlusion (≥ 3 months of occlusion)) Exclusion Criteria: 1. Age less than 18 years; 2. Unable to give informed consent or currently participating in other trials; 3. Patient who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to randomization in women of child-bearing potential according to local practice), or plans to become pregnant during treatment; 4. Concurrent medical condition with a life expectancy of less than 3 years; 5. Hemodynamic unstable; 6. Active liver disease or hepatic dysfunction (persistent unexplained ALT/AST elevations (≥ 3 × ULN)), patients with a transient increase ALT/AST due to the acute MI may be enrolled; 7. Unable to reach the LDL-C target by known intolerance or contradiction of lipid control medications; 8. LDL-C ≤ 1.4 mmol/L at baseline without any lipid control medication lowering LDL-C; 9. Known active infection or critical hematologic/endocrine dysfunction.

Locations (1)

Xijing Hospital

Xi'an, Shannxi, China