NCT06821711Not yet recruiting
Optimal LDL-C Target in High-risk Patients After PCI
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)
Source: ClinicalTrials.gov · Last updated 19 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 12000 (estimated)
- First submitted
- 6 Feb 2025
- Start date
- 20 Feb 2025
- Primary completion date
- 15 Aug 2029
- Lead sponsor
- Xijing Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT06821711
What you commit to
- Study type: Interventional
- Planned participants: 12000
- From 20 Feb 2025 to the primary completion date, 15 Aug 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
- Concurrent medical condition with a life expectancy of less than 3 years;
- Unable to reach the LDL-C target by known intolerance or contradiction of lipid control medications;
Other illness
- Known active infection or critical hematologic/endocrine dysfunction.
Lab values
- 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;
- LDL-C ≤ 1.4 mmol/L at baseline without any lipid control medication lowering LDL-C;
Age
- Age less than 18 years;
Other
- Unable to give informed consent or currently participating in other trials;
- Hemodynamic unstable;
Who the study is looking for
- Patients underwent percutaneous coronary intervention due to acute or chronic coronary syndrome
- Patients with ASCVD at extremely high risk
- 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:
- PCI for acute myocardial infarction (AMI, including STEMI or NSTEMI)
- Previous AMI, previous stroke, or previous intervention or surgery for peripheral vascular disease
- Experienced cardiovascular event(s) with LDL-C≤1.8mmol/L
- LDL-C≥4.9mmol/L
- Diabetes
- CKD (eGFR \< 60 ml/min/1.73m2)
- Current smoking
- Recurrent cardio/cerebrovascular events
- History of premature ASCVD (\< 55 male, \< 65 female)
- 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))
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xijing hospital Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.