Clinical trial NCT03770312: Low- and Moderate-intensity Statin and Clinical Outcome of Primary Prevention in Individuals Aged >75 Years: the SCOPE-75 RCT Study
Official title: Low- and Moderate-intensity Statin and Clinical Outcome of Primary Prevention in Individuals Aged >75 Years: the SCOPE-75 RCT Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Healthy Elderly Individuals With High LDL-cholesterol or Risk of Cardiovascular Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-12-10
Enrollment: 2484
Sex: ALL
Minimum age (years): 76
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Statin associated muscle symptoms (SAMS) -If all of the following occur, it is defined as SAMS.
timeFrame: 3 months
measure: Statin associated muscle symptoms (SAMS) -If all of the following occur, it is defined as SAMS.
timeFrame: 6 months
measure: Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form Brief Pain Inventory (BPI-SF).
timeFrame: 3 months
measure: Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form Brief Pain Inventory (BPI-SF).
timeFrame: 6 months
measure: Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form McGill Pain Questionnaire (SF-MPQ)
timeFrame: 3 months
measure: Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form McGill Pain Questionnaire (SF-MPQ)
timeFrame: 6 months
Secondary outcomes:
measure: Clinical outcomes
timeFrame: 4 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Cardiovascular Center, Severance Hospital, Yonsei University College of Medicine
Study officials:
References: