Status:
RECRUITING
Low- and Moderate-intensity Statin and Clinical Outcome of Primary Prevention in Individuals Aged >70 Years: the SCOPE-70 RCT Study
Lead Sponsor:
Yonsei University
Conditions:
Healthy Elderly Individuals With High LDL-cholesterol or Risk of Cardiovascular Disease
Eligibility:
All Genders
70+ years
Phase:
PHASE4
Brief Summary
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 elder...
Detailed Description
This study is a multicenter, prospective, randomized clinical trial evaluating the safety of low-intensity statins versus moderate-intensity statins in the primary prevention of cardiovascular disease...
Eligibility Criteria
Inclusion
- "Inclusion criteria
- Adults aged 70 years or older as of the date of written consent, meeting one of the criteria in items 2-5)
- Patients with no prior statin use or who have discontinued statin therapy for at least 4 weeks, with no cardiovascular risk factors\* and LDL-cholesterol levels of 160-189 mg/dL
- Patients with no prior statin use or who have discontinued statins for at least 4 weeks, with one or more cardiovascular disease risk factors\* and LDL-cholesterol levels of 80-189 mg/dL
- For patients currently taking statins, with 0 cardiovascular disease risk factors\* and LDL-cholesterol levels of 95-114 mg/dL
- For patients currently taking statins, with 1 or more cardiovascular disease risk factors\* and LDL-cholesterol levels of 50-114 mg/dL
- Cardiovascular Disease Risk Factors
- Male
- Family history of early cardiovascular disease: myocardial infarction, angina, peripheral vascular disease, ischemic stroke; men \<55 years, women \<65 years
- Diabetes: One or more of the following five criteria: HbA1c ≥6.5%, fasting blood glucose ≥126 mg/dL, postprandial 2-hour blood glucose ≥200 mg/dL, random blood glucose ≥200 mg/dL with typical symptoms like polyuria, or the use of antidiabetic medication
- Hypertension: Systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, or use of antihypertensive medication
- Current smoker
- HDL-cholesterol \<40 mg/dL
- Exclusion criteria (any):
- Individuals who have been diagnosed with cancer within the last 5 years.
- Individuals who have high level of serum ALT (\>2 upper normal limit).
- Individuals who have serum creatinine ≥2 mg/dL.
- Individuals who have been diagnosed with cardiovascular disease (\>50% stenosis of coronary artery on imaging study, percutaneous transluminal coronary angioplasty, coronary artery bypass graft, or myocardial infarction).
- Individuals who have been diagnosed with peripheral artery disease (\>50% stenosis of peripheral artery on imaging study, or ankle brachial index \<0.9 or ≥1.3).
- Individuals who have been diagnosed with uncontrolled hyperthyrodism or hypothyroidism.
- Individuals who are taking drug that can interact with statin.
- Individuals who have physical disability to live daily life.
- Individuals with genetic disorders such as galactose intolerance (including preparations containing lactose)"
Exclusion
Key Trial Info
Start Date :
March 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 16 2026
Estimated Enrollment :
724 Patients enrolled
Trial Details
Trial ID
NCT03770312
Start Date
March 5 2020
End Date
January 16 2026
Last Update
November 18 2025
Active Locations (1)
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1
Division of Cardiology, Cardiovascular Center, Severance Hospital, Yonsei University College of Medicine
Seoul, South Korea, 03722