Actively Recruiting
LDL Cholesterol TARGETs in OLDer Patients (Age≥75 Years) With ASCVD (TARGET OLD)
Led by China National Center for Cardiovascular Diseases · Updated on 2023-04-10
4200
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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) with at least one of the following: coronary heart disease, atherosclerotic cerebrovascular or carotid disease, or atherosclerotic peripheral artery disease
- Baseline LDL-C level of 100 mg/dL or higher if on lipid-lowering therapy for less than 4 weeks or no prior therapy
- Baseline LDL-C level of 70 mg/dL or higher 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 hypotension due to cardiac failure, severe pulmonary edema, acute mitral regurgitation, cardiogenic shock, or ongoing heart attacks
- Moderate to severe heart failure (NYHA Class III or IV) or left ventricular ejection fraction below 40%
- Severe renal dysfunction with creatinine clearance less than 30 mL/min or requiring dialysis
- History of hemorrhagic or unknown type stroke
- Uncontrolled or recurrent dangerous heart rhythm problems
- Uncontrolled high blood pressure above 180/110 mm Hg at screening
- Active liver disease or significant liver function abnormalities
- Unexplained high creatine kinase levels or known muscle disease
- Planned major heart or non-heart surgery during the study
- Active cancer requiring recent treatment, except some skin and early-stage cancers
- Drug or alcohol abuse or inability to abstain during the study
- Severe non-cardiovascular illness expected to limit life expectancy to under 3 years
- Participation in another investigational drug or device study within 30 days
- Use of medications that strongly interact with statins within 1 month prior to randomization
- Major organ transplant recipient
- Likely inability to complete study visits or comply with procedures
- Any uncontrolled or serious disease that may interfere with participation or increase risk
- Mental or cognitive impairment affecting study compliance or understanding of risks and goals
AI-Screening
AI-Powered Screening
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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
CONTACT
H
Hao-Yu Wang, MD, PhD
CONTACT
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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