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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0003629

Enrollment

2484

Registered

2019-03-15

Start date

2019-04-16

Completion date

Unknown

Last updated

2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : 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 gro

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Clinical outcomes	—

Countries

Korea, Republic of

Contacts

Public ContactSanghak Lee

Yonsei University Health System, Severance Hospital

Outcome results