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

Summary

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.

Conditions

• Atherosclerotic Cardiovascular Disease
• Older Patients
• LDL Cholesterol

Interventions

PROCEDURE

Achieving a Target LDL-C level of 25mg/dL≤ LDL-C<70mg/dL

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.

PROCEDURE

Achieving a Target LDL-C level of 70mg/dL≤ LDL-C<100mg/dL

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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases

  lead OTHER_GOV

Principal Investigators

• Kefei Dou, MD, PhD · Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing

• Hao-Yu Wang, MD, PhD · Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-03-24

Primary Completion

2026-09-24

Completion

2026-12-24

Countries

• China

Study Locations