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

NCT03770312 · tracked via the Priya Life Science South Korea tracker

Sponsor

Yonsei University

Phase

Phase 4

Started

2020-03-05

Last updated

2025-11-18

Condition(s) studied

Healthy Elderly Individuals With High LDL-cholesterol or Risk of Cardiovascular Disease

Investigational drug(s) / intervention(s)

Low intensity statin →Moderate intensity statin →

Low intensity statin: Use of low intensity statin for primary prevention of cardiovascular disease.

Moderate intensity statin: Use of moderate intensity statin for primary prevention of cardiovascular disease.

Study 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 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.

Eligibility

Sex

ALL

Min age

70 Years

Max age

—

Healthy volunteers

Accepted

"Inclusion criteria 1. Adults aged 70 years or older as of the date of written consent, meeting one of the criteria in items 2-5) 2. 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 3. 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 4. For patients currently taking statins, with 0 cardiovascular disease risk factors\* and LDL-cholesterol levels of 95-114 mg/dL 5. 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): 1. Individuals who have been diagnosed with cancer within the last 5 years. 2. Individuals who have high level of serum ALT (\>2 upper normal limit). 3. Individuals who have serum creatinine ≥2 mg/dL. 4. 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). 5. 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). 6. Individuals who have been diagnosed with uncontrolled hyperthyrodism or hypothyroidism. 7. Individuals who are taking drug that can interact with statin. 8. Individuals who have physical disability to live daily life. 9. Individuals with genetic disorders such as galactose intolerance (including preparations containing lactose)"

Primary outcome measure(s)

Statin associated muscle symptoms (SAMS) -If all of the following occur, it is defined as SAMS. — 3 months
1. They report new or increased myalgia, cramps, or muscle aching, unassociated with recent exercise. 2. These symptoms have persisted for at least 2 weeks. 3. The symptoms resolve within 2 weeks of stopping the study drug. 4. The symptoms reoccur within 4 weeks of restarting the medication.
Statin associated muscle symptoms (SAMS) -If all of the following occur, it is defined as SAMS. — 6 months
1. They report new or increased myalgia, cramps, or muscle aching, unassociated with recent exercise. 2. These symptoms have persisted for at least 2 weeks. 3. The symptoms resolve within 2 weeks of stopping the study drug. 4. The symptoms reoccur within 4 weeks of restarting the medication.
Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form Brief Pain Inventory (BPI-SF). — 3 months
Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form Brief Pain Inventory (BPI-SF). — 6 months
Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form McGill Pain Questionnaire (SF-MPQ) — 3 months
Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form McGill Pain Questionnaire (SF-MPQ) — 6 months

Trial sites (1)

Facility	City	Region	Status
Division of Cardiology, Cardiovascular Center, Severance Hospital, Yonsei University College of Medicine	Seoul	South Korea	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03770312 on ClinicalTrials.gov ↗ ← All trials in South Korea