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

NCT ID: NCT03770312

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 724 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-05
• Study Completion Date: 2026-01-16

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 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.

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 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Low intensity statin group

Taking low intensity statin

Group Type: ACTIVE_COMPARATOR

Low intensity statin

Intervention Type: DRUG

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

Moderate intensity statin group

Taking moderate intensity statin

Group Type: ACTIVE_COMPARATOR

Moderate intensity statin

Intervention Type: DRUG

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

Interventions

Low intensity statin

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

Intervention Type: DRUG

Moderate intensity statin

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

Intervention Type: DRUG

Eligibility Criteria

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

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)"

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Division of Cardiology, Cardiovascular Center, Severance Hospital, Yonsei University College of Medicine

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Facility Contacts

Sang-Hak Lee, MD

Role: primary

SHL1106@yuhs.ac

82-2-2228-8460

Other Identifiers

4-2019-1219

Identifier Type: -

Identifier Source: org_study_id