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

• Status: Not yet recruiting
• Trial end date: 2026-01-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yonsei University
• Treatments: Hydroxymethylglutaryl-CoA Reductase Inhibitors

Criteria

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