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ow- and moderate-intensity Statin and Clinical Outcome of Primary prevention in individuals aged >75 years: the SCOPE-75 RCT Study

Not Applicable
Terminated
Conditions
Diseases of the circulatory system
Registration Number
KCT0003629
Lead Sponsor
Yonsei University Health System, Severance Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Terminated
Sex
All
Target Recruitment
2484
Inclusion Criteria

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).

Exclusion Criteria

1) Individuals who have been diagnosed with cancer within the last 5 years.
2) Individuals who have high level of serum AST and ALT (>2 upper normal limit).
3) Individuals who have muscular disease such as Myopathy or Rhabdomyolysis or who have high level of CK (>2 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 uncontrolled hyperthyrodism or hypothyroidism.
8) Individuals who are taking drug that can interact with statin.
9) Individuals who have physical disability to live daily life.

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Statin associated muscle symptoms (SAMS): Short-Form McGill Pain Questionnaire (SF-MPQ);Statin associated muscle symptoms (SAMS): Short-Form Brief pain Inventory (BPI-SF)
Secondary Outcome Measures
NameTimeMethod
Clinical outcomes
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