ow- and moderate-intensity Statin and Clinical Outcome of Primary prevention in individuals aged >70 years: the SCOPE-70 RCT Study
- Conditions
- Endocrine, nutritional and metabolic diseases
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 2484
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-cholseterol 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).
1) Individuals who have been diagnosed with cancer within the last 5 years.
2) Individuals who have high level of serum AST, ALT (>2 upper normal limit).
3) past history of myopathy or rhabdomyolysis or 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 hyperthyrodism 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Statin associated muscle symptoms (SAMS) : Statin associated muscle symptoms are judged using the Short-Form McGill Pain Questionnaire (SF-MPQ) and the Short-Form Brief Pain Inventory (BPI-SF). If all of the following occur, it is defined as SAMS. 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.
- Secondary Outcome Measures
Name Time Method 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