NCT03770312

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 724 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Low intensity statin	Use of low intensity statin for primary prevention of cardiovascular disease.
DRUG	Moderate intensity statin	Use of moderate intensity statin for primary prevention of cardiovascular disease.

Timeline

• Start date: 2020-03-05
• Primary completion: 2026-01-16
• Completion: 2026-01-16
• First posted: 2018-12-10
• Last updated: 2025-11-18

Locations

1 site across 1 country: South Korea