Low- and Moderate-intensity Statin and Clinical Outcome of Primary Prevention in Individuals Aged >70 Years: the SCOPE-70 RCT Study

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 in elderly patients aged 70 years or older without cardiovascular disease. The patient recruitment period is 2 years, with a 6-month follow-up period (a 4-year follow-up is optional).

Individuals deemed eligible through screening will be randomly assigned in a 1:1 ratio to either the rosuvastatin 2.5mg or rosuvastatin 10mg group. After randomization, subjects will visit at 3 and 6 months for scheduled blood tests, physical examinations, and questionnaires regarding muscle symptoms. After 6 months, subjects may optionally continue routine primary cardiovascular disease prevention care for a total of 4 years of follow-up.

"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)"