Xijing Hospital
Xi'an, Shannxi, 710032, China
NCT Number: NCT06821711
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Xi'an, Shannxi, 710032, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: 24 months
MACCE, a composite of cardiovascular death, stroke, myocardial infarction, and any revascularization.
Time frame: 24 months
PoCE, a composite of all-cause death, stroke, myocardial infarction, revascularization, is the first major secondary outcome.
Time frame: 24 months
DoCE, a composite of cardiovascular death, target vessel myocardial infarction, clinically and physiologically-indicated target lesion revascularization, is the second major secondary outcome.
Time frame: 24 months
The composite of all-cause death, stroke, and myocardial infarction is the third major secondary outcome.
Time frame: 24 months
All-cause death is considered as other secondary endpoint
Time frame: 24 months
Cardiovascular death is considered as other secondary endpoint
Time frame: 24 months
Myocardial infarction is considered as other secondary endpoint
Time frame: 24 months
Stroke is considered as other secondary endpoint
Time frame: 24 months
Ischemic stroke is considered as other secondary endpoint
Time frame: 24 months
Hemorrhagic stroke is considered as other secondary endpoint
Time frame: 24 months
Revascularization is considered as other secondary endpoint
Time frame: 24 months
Target lesion revascularization is considered as other secondary endpoint
Time frame: 24 months
Clinically and physiologically-indicated target lesion revascularization is considered as other secondary endpoint
Time frame: 24 months
Cardiovascular hospitalization is considered as other secondary endpoint
Time frame: 24 months
EuroQol-5D-5L is considered as exploratory endpoint
Time frame: 24 months
Everyday Cognition Questionnaire is considered as exploratory endpoint
Time frame: 24 months
Pharmacological costs is considered as exploratory endpoint
Time frame: 24 months
All adverse events is defined by CTCAE V5.0, considered as safety endpoint
Time frame: 24 months
All serious adverse events is defined by CTCAE V5.0, considered as safety endpoint
Time frame: 24 months
Adverse events of interest, including minor bleeding, major bleeding, injection site reactions, allergic reactions, muscle-related adverse events, rhabdomyolysis, cataracts, adjudicated case of new-onset diabetes, neurocognitive disorders, AST/ALT elevation >3 times the upper limit of normal, creatine kinase elevation >5 times the upper limit of normal, which is considered as safety endpoint
Adverse events of interest is the safety endpoint.
Contact information is provided by the study sponsor or research team.
Xijing Hospital
Other
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)
Acronym: REC-SAFETARGET
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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