Actively Recruiting
LDL Cholesterol TARGETs in OLDer Patients (Age≥75 Years) With Atherosclerotic Cardiovascular Disease (TARGET OLD)
Led by China National Center for Cardiovascular Diseases · Updated on 2023-04-10
4200
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether lowering LDL cholesterol (LDL-C) to a target range of 25 to less than 70 mg/dL is better than a target range of 70 to less than 100 mg/dL for preventing major cardiovascular events in patients aged 75 years or older with atherosclerotic cardiovascular disease (ASCVD). The study also examines if the lower LDL-C target is as safe as the higher target regarding major safety events like hemorrhagic stroke, new diabetes, muscle problems, neurocognitive issues, cancer, cataracts, or liver disorders. This trial addresses the uncertainty about optimal LDL-C targets in older adults, as most previous studies excluded this age group. Participants are randomly assigned to one of two groups with different LDL-C targets: either 25 to less than 70 mg/dL or 70 to less than 100 mg/dL. Doctors adjust lipid-lowering medications, including statins, ezetimibe, or PCSK9 inhibitors, to help patients reach their assigned LDL-C goal. Follow-up visits occur at 1, 2, 4, 6, and 12 months, then every 6 months up to 36 months, with ongoing monitoring of LDL-C levels, cardiovascular events, safety issues, muscle symptoms, quality of life, and cognitive function. The study will continue until 726 major cardiovascular events are confirmed. During the study, participants undergo regular lab tests to measure lipid profiles and are assessed for any cardiovascular or safety events. Patient-reported quality of life and cognitive function are also evaluated using standardized questionnaires. Researchers will analyze time to first major cardiovascular event and major safety events over an average follow-up of about 42 months. All evaluations follow the intention-to-treat principle, ensuring all patients are included in the analysis regardless of treatment adherence.
CONDITIONS
Brief Title
LDL Cholesterol TARGETs in OLDer Patients (Age≥75 Years) With ASCVD (TARGET OLD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women 75 years of age or older
- Diagnosis of clinical atherosclerotic cardiovascular disease (ASCVD), including coronary heart disease, cerebrovascular or carotid disease, or peripheral artery disease
- Baseline LDL cholesterol level of at least 100 mg/dL if on lipid-lowering therapy less than 4 weeks or no prior lipid-lowering therapy
- Baseline LDL cholesterol level of at least 70 mg/dL if on stable lipid-lowering therapy for 4 weeks or more
- Signed written informed consent
You will not qualify if you...
- Clinically unstable conditions such as sustained low blood pressure due to heart failure, severe pulmonary edema, acute mitral regurgitation, cardiogenic shock, ongoing acute heart attacks, or recurrent cardiac ischemia
- Moderate to severe heart failure (NYHA class III or IV) or left ventricular ejection fraction less than 40%
- Severe kidney dysfunction with creatinine clearance less than 30 mL/min or need for dialysis
- History of hemorrhagic or unknown stroke
- Uncontrolled or recurrent serious heart rhythm problems
- Uncontrolled high blood pressure (above 180/110 mm Hg)
- Active liver disease or significant liver dysfunction
- Unexplained high creatine kinase levels or known muscle disease
- Planned major cardiac or noncardiac surgery during the study period
- Active malignancy requiring recent treatment, except certain early-stage cancers
- Drug or alcohol abuse or inability to abstain during the study
- Severe noncardiovascular diseases expected to reduce life expectancy under 3 years
- Current or recent participation in other investigational drug or device studies
- Use of drugs with major interactions with statins within 1 month before randomization
- Recipient of major organ transplant
- Unlikely to complete all study visits or comply with study procedures
- Uncontrolled or serious diseases or conditions that may interfere with study participation
- Mental or cognitive impairments that may affect understanding or compliance with the study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 42 months
Participants are randomized to receive lipid-lowering treatment targeting either LDL cholesterol levels of 25 to less than 70 mg/dL or 70 to less than 100 mg/dL. Medication doses may be adjusted to achieve the assigned LDL cholesterol target.
Visits at 1, 2, 4, 6, and 12 months, then every 6 months thereafter
Trial Site Locations
Total: 1 location
1
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100037
Actively Recruiting
Research Team
K
Kefei Dou, MD, PhD
H
Hao-Yu Wang, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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