Low- and moderate-intensity Statin and Clinical Outcome of Primary prevention in individuals aged >70 years: the SCOPE-70 RCT Study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0004711

Enrollment

2484

Registered

2020-02-06

Start date

2020-04-17

Completion date

Unknown

Last updated

2022-10-24

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, 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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public Contactsang hak Lee

Yonsei University Health System, Severance Hospital

shl1106@hanmail.net+82-2-2228-8456

Outcome results