LDL Cholesterol TARGETs in OLDer Patients (Age≥75 Years) With ASCVD (TARGET OLD)

ConditionsAtherosclerotic Cardiovascular Disease Older Patients LDL Cholesterol

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Achieving a Target LDL-C level of 25mg/dL≤ LDL-C<70mg/dL
Procedure/Surgery
Investigators initiated or adjusted lipid-lowering agents (drug and dosage) to achieve the target of 25mg/dL≤ LDL-C\<70mg/dL. The protocol encouraged, but did not mandate, the initiation of moderate-intensity statin therapy for secondary prevention with the evaluation of the potential for ASCVD risk reduction, adverse effects, and drug-drug interactions, as well as patient frailty and patient preferences. Statin monotherapy or in combination with ezetimibe, PCSK9 inhibitor or other drugs were adjusted on the basis of LDL-C levels. At each follow-up visit, the investigators should verify whether the target LDL-C has been obtained. If the target level of LDL cholesterol was achieved, it is reasonable to continue to monitor adherence to lifestyle modiﬁcations, medication, and ongoing LDL-C response to therapy. If the target level of LDL cholesterol was not achieved, adjustment of the type and dose regimen of statin, or the additional of a nonstatin agent should be considered.
Achieving a Target LDL-C level of 70mg/dL≤ LDL-C<100mg/dL
Procedure/Surgery
Investigators initiated or adjusted lipid-lowering agents (drug and dosage) to achieve the target of 70mg/dL≤ LDL-C\<100mg/dL. The protocol encouraged, but did not mandate, the initiation of moderate-intensity statin therapy for secondary prevention with the evaluation of the potential for ASCVD risk reduction, adverse effects, and drug-drug interactions, as well as patient frailty and patient preferences. Statin monotherapy or in combination with ezetimibe, PCSK9 inhibitor or other drugs were adjusted on the basis of LDL-C levels. At each follow-up visit, the investigators should verify whether the target LDL-C has been obtained. If the target level of LDL cholesterol was achieved, it is reasonable to continue to monitor adherence to lifestyle modiﬁcations, medication, and ongoing LDL-C response to therapy. If the target level of LDL cholesterol was not achieved, adjustment of the type and dose regimen of statin, or the additional of a nonstatin agent should be considered.

Treatment groups

4,200 Participants

are divided into 2 treatment groups

Group A: LDL-C Lower-Target Group (25mg/dL≤ LDL-C<70mg/dL)Experimental treatment 1 intervention

Group B: LDL-C Higher-Target Group (70mg/dL≤ LDL-C<100mg/dL)Active comparator 1 intervention

Trial outcomes

Primary outcomes

Time to first occurrence of major cardiovascular events (composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, coronary revascularization)

The primary endpoint measure was the number of patients with a first occurrence of adjudicated composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization during the follow-up period.

Time frame

From randomization until study completion (until 726 adjudicated primary endpoint events have occurred); for approximately a median follow-up of 42 months

Secondary outcomes

Time to first occurrence of major safety events (composite of hemorrhagic stroke, new-onset diabetes, muscle-related events, neurocognitive adverse events, new or progressive cancer, cataract, or hepatic disorder).

The key secondary endpoint measure was the number of patients with a first occurrence of adjudicated composite of hemorrhagic stroke, new-onset diabetes, muscle-related events, neurocognitive adverse events, new or progressive cancer, cataract, or hepatic disorder (ALT/AST \>3× ULN, or total bilirubin \>2× ULN) during the follow-up period.

Time frame

From randomization until study completion (until 726 adjudicated primary endpoint events have occurred); for approximately a median follow-up of 42 months

Time to first occurrence of composite endpoint of cardiovascular death, myocardial infarction, stroke, or coronary revascularization.

Number of patients with a first occurrence of adjudicated composite of cardiovascular death, myocardial infarction, stroke, or coronary revascularization during the follow-up period.

Time frame

From randomization until study completion (until 726 adjudicated primary endpoint events have occurred); for approximately a median follow-up of 42 months.

Time to first occurrence of composite endpoint of cardiovascular death, myocardial infarction, or stroke.

Number of patients with a first occurrence of adjudicated composite of cardiovascular death, myocardial infarction, or stroke during the follow-up period.

Time frame

From randomization until study completion (until 726 adjudicated primary endpoint events have occurred); for approximately a median follow-up of 42 months.

Time to first occurrence of composite endpoint of all-cause death, myocardial infarction, or stroke.

Number of patients with a first occurrence of adjudicated composite of all-cause death, myocardial infarction, or stroke during the follow-up period.

Time frame

From randomization until study completion (until 726 adjudicated primary endpoint events have occurred); for approximately a median follow-up of 42 months.

Other outcomes

Health-related Quality-of-life outcome

Quality of life as measured by European Quality of Life-5 Dimensions (EQ-5D-5L)

Time frame

Baseline, 30 days, 6 months, 1 year, and then every 6 months until study completion (726 adjudicated primary endpoint events have occurred)

Patient-reported cognition function

Patient-reported cognition function as measured by Everyday Cognition (ECog) scale

Time frame

Baseline, 30 days, 6 months, 1 year, and then every 6 months until study completion (726 adjudicated primary endpoint events have occurred).

Sponsors and contacts

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China National Center for Cardiovascular Diseases

Lead sponsor

Source ClinicalTrials.gov

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