Actively Recruiting
Low- and Moderate-intensity Statin and Clinical Outcome of Primary Prevention in Individuals Aged >70 Years: the SCOPE-70 RCT Study
Led by Yonsei University · Updated on 2025-11-18
724
Participants Needed
1
Research Sites
306 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
One of the most effective drug in the primary prevention of cardiovascular disease is statins. The protective effects of statin on developement of cardiovascular disease has been demonstrated in elderly individuals. Since side effects of statin are more common in elderly individuals than in younger individuals, clinical guidelines recommend that use of low intensity statin is considered in elderly individuals. However, there are few randomized clinical trials evaluating the safety and efficacy of different intensity statins in elderly individuals. This is a multicenter, prospective, randomized clinical trial to compare efficacy and safety between low and high intensity statin for primary prevention of cardiovacsular disease in elderly individuals.
CONDITIONS
Official Title
Low- and Moderate-intensity Statin and Clinical Outcome of Primary Prevention in Individuals Aged >70 Years: the SCOPE-70 RCT Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 70 years or older at consent meeting one of the following criteria:
- No prior statin use or stopped statins for at least 4 weeks with no cardiovascular risk factors and LDL-cholesterol 160-189 mg/dL
- No prior statin use or stopped statins for at least 4 weeks with one or more cardiovascular risk factors and LDL-cholesterol 80-189 mg/dL
- Currently taking statins with no cardiovascular risk factors and LDL-cholesterol 95-114 mg/dL
- Currently taking statins with one or more cardiovascular risk factors and LDL-cholesterol 50-114 mg/dL
- Cardiovascular disease risk factors include male sex, family history of early cardiovascular disease, diabetes, hypertension, current smoking, and low HDL-cholesterol (<40 mg/dL)
You will not qualify if you...
- Diagnosed with cancer within the last 5 years
- High serum ALT level (more than twice the upper normal limit)
- Serum creatinine level 2 mg/dL or higher
- Diagnosed cardiovascular disease including coronary artery stenosis >50%, coronary interventions, or myocardial infarction
- Diagnosed peripheral artery disease with >50% stenosis, or abnormal ankle brachial index (<0.9 or >1.3)
- Uncontrolled hyperthyroidism or hypothyroidism
- Taking drugs that interact with statins
- Physical disability limiting daily life
- Genetic disorders such as galactose intolerance (including lactose-containing preparations)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Division of Cardiology, Cardiovascular Center, Severance Hospital, Yonsei University College of Medicine
Seoul, South Korea, 03722
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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