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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: Low intensity statin
* Drug: Moderate intensity statin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (1 and, 2 or 3) Individuals aged 76-85 years old. Individuals who have serum LDL-cholesterol of 160-189 mg/dL. 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) Individuals who have been diagnosed with cancer within the last 5 years. Individuals who have high level of serum aspartate aminotransferase (AST), alanine amino- transferse (ALT) (>2 upper normal limit). past history of myopathy or rhabdomyolysis or Creatine Kinase (CK)> 2-fold of 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 hyperthyroidism or hypothyroidism. Individuals who are taking drug that can interact with statin. Individuals who have physical disability to live daily life. genetic disorder such as galactose intolerance, etc

Ages Eligible for Study
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Minimum Age: 76 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low intensity statin group<br>Taking low intensity statin | Drug: Low intensity statin<br>* Use of low intensity statin for primary prevention of cardiovascular disease.<br>|
| Active Comparator: Moderate intensity statin group<br>Taking moderate intensity statin | Drug: Moderate intensity statin<br>* Use of moderate intensity statin for primary prevention of cardiovascular disease.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Statin associated muscle symptoms (SAMS) -If all of the following occur, it is defined as SAMS. | They report new or increased myalgia, cramps, or muscle aching, unassociated with recent exercise. These symptoms have persisted for at least 2 weeks. The symptoms resolve within 2 weeks of stopping the study drug. The symptoms reoccur within 4 weeks of restarting the medication. | 3 months | 
| Statin associated muscle symptoms (SAMS) -If all of the following occur, it is defined as SAMS. | They report new or increased myalgia, cramps, or muscle aching, unassociated with recent exercise. These symptoms have persisted for at least 2 weeks. The symptoms resolve within 2 weeks of stopping the study drug. The symptoms reoccur within 4 weeks of restarting the medication. | 6 months | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcomes | cardiovascular death nonfatal myocardial infarction nonfatal ischemic stroke or transient ischemic attack coronary revascularization (percutaneous coronary intervention, coronary artery bypass graft) hospitalization for unstable angina | 4 years |