LDL Cholesterol TARGETs in OLDer Patients (Age≥75 Years) With ASCVD (TARGET OLD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age75+
SponsorChina National Center for Cardiovascular Diseases
About this trial
To determine whether treating to an LDL-C target of 25 to \<70 mg/dL is superior to an LDL-C target of 70 to \<100 mg/dL with respect to major cardiovascular events (cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization) in patients aged ≥75 years with atherosclerotic cardiovascular disease (ASCVD).
To determine whether treating to an LDL-C target of 25 to \<70 mg/dL is non-inferior to an LDL-C target of 70 to \<100 mg/dL with respect to major safety events (hemorrhagic stroke, new-onset diabetes, muscle-related events, neurocognitive adverse events, new or recurrent cancer, cataract, or hepatic disorder \[Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) \>3× ULN, or total bilirubin \>2× ULN\]) in patients aged ≥75 years with ASCVD.
Eligibility criteria
Qualifiers
Men or women ≥75 years of age
Hospitalization for acute coronary syndrome
Treatment or hospitalization for stable angina pectoris with documented ischemia on invasive or noninvasive testing
History of myocardial infarction
Disqualifiers
Hypotension, defined as sustained systolic blood pressure of <90 mmHg due to cardiac failure with associated symptoms;
Unstable or severe pulmonary edema/decompensated congestive heart failure;
Acute mitral regurgitation or acute ventricular septal defect;
Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support
Trial design
Treatments tested in this trial
- Achieving a Target LDL-C level of 25mg/dL≤ LDL-C<70mg/dL
- Achieving a Target LDL-C level of 70mg/dL≤ LDL-C<100mg/dL
Treatment groups
4,200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov