Low- and Moderate-intensity Statin and Clinical Outcome of Primary Prevention in Individuals Aged >75 Years: the SCOPE-75 RCT Study

Phase 4

Not yet recruiting

• Conditions: Healthy Elderly Individuals With High LDL-cholesterol or Risk of Cardiovascular Disease
• Interventions: Drug: Low intensity statin; Drug: Moderate intensity statin

• Registration Number: NCT03770312
• Lead Sponsor: Yonsei University

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 aged over 75 years. 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 cardiovascular disease in elderly individuals.

Detailed Description

Healthy elderly individuals who are eligible to use of statin for primary prevention will be enrolled. They are randomly assigned to moderate intensity statin group and low intensity statin group by 1:1 manner. Blood tests, physical examinations, and evaluation of statin associated muscle symptoms are conducted every 3 months after enrollment. General medical care for prevention of cardiovascular disease is continued after 6 months. The accrual period is 2 years and follow-up period is 4 years, so the total study period is 6 years.

Study Timeline

• Study First Submitted: 2018-12-04
• Study First Submitted QC: 2018-12-06
• Study First Posted: 2018-12-10
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-06
• Study Start: 2020-03-05
• Primary Completion: 2026-01-16
• Study Completion: 2026-01-16

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2484

Inclusion Criteria

(1 and, 2 or 3)

1. Individuals aged 76-85 years old.
2. Individuals who have serum LDL-cholesterol of 160-189 mg/dL.
3. Individuals who have serum LDL-cholesterol of 80-159 mg/dL and ≥1 cardiovascular risk factor (male, diabetes, hypertension, smoking, serum HDL-cholesterol <40 mg/dL, or family history of premature cardiovascular disease).

Exclusion Criteria

(any)

1. Individuals who have been diagnosed with cancer within the last 5 years.
2. Individuals who have high level of serum aspartate aminotransferase (AST), alanine amino- transferse (ALT) (>2 upper normal limit).
3. past history of myopathy or rhabdomyolysis or Creatine Kinase (CK)> 2-fold of upper normal limit
4. Individuals who have serum creatinine ≥2 mg/dL.
5. 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).
6. 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).
7. Individuals who have been diagnosed with hyperthyroidism or hypothyroidism.
8. Individuals who are taking drug that can interact with statin.
9. Individuals who have physical disability to live daily life.
10. genetic disorder such as galactose intolerance, etc

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low intensity statin group	Low intensity statin	Taking low intensity statin
Moderate intensity statin group	Moderate intensity statin	Taking moderate intensity statin

Primary Outcome Measures

Name	Time	Method
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).	6 months
Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form McGill Pain Questionnaire (SF-MPQ)	6 months

Secondary Outcome Measures

Name	Time	Method
Clinical outcomes	4 years	1. cardiovascular death; 2. nonfatal myocardial infarction; 3. nonfatal ischemic stroke or transient ischemic attack; 4. coronary revascularization (percutaneous coronary intervention, coronary artery bypass graft); 5. hospitalization for unstable angina

Trial Locations

Locations (1)

Division of Cardiology, Cardiovascular Center, Severance Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of