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. 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 cardiovacsular disease in elderly individuals.
This study is a multicenter, prospective, randomized clinical trial evaluating the safety of low-intensity statins versus moderate-intensity statins in the primary prevention of cardiovascular disease in elderly patients aged 70 years or older without cardiovascular disease. The patient recruitment period is 2 years, with a 6-month follow-up period (a 4-year follow-up is optional). Individuals deemed eligible through screening will be randomly assigned in a 1:1 ratio to either the rosuvastatin 2.5mg or rosuvastatin 10mg group. After randomization, subjects will visit at 3 and 6 months for scheduled blood tests, physical examinations, and questionnaires regarding muscle symptoms. After 6 months, subjects may optionally continue routine primary cardiovascular disease prevention care for a total of 4 years of follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
724
Use of low intensity statin for primary prevention of cardiovascular disease.
Use of moderate intensity statin for primary prevention of cardiovascular disease.
Division of Cardiology, Cardiovascular Center, Severance Hospital, Yonsei University College of Medicine
Seoul, South Korea
RECRUITINGStatin associated muscle symptoms (SAMS) -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.
Time frame: 3 months
Statin associated muscle symptoms (SAMS) -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.
Time frame: 6 months
Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form Brief Pain Inventory (BPI-SF).
Time frame: 3 months
Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form Brief Pain Inventory (BPI-SF).
Time frame: 6 months
Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form McGill Pain Questionnaire (SF-MPQ)
Time frame: 3 months
Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form McGill Pain Questionnaire (SF-MPQ)
Time frame: 6 months
Clinical outcomes
Major adverse cardiovascular events, defined as the composite endpoint comprised of cardiovascular death, nonfatal MI, nonfatal ischemic stroke, TIA, coronary revascularization (PCI or CABG), or hospitalization for unstable angina during extended follow-up up to 48 months. All adverse events during 6 months.
Time frame: 4 years for MACE. 6 months for all adverse events.
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