Healthy Elderly Individuals With High LDL-cholesterol or Risk of Cardiovascular Disease Clinical Trial
Official title:
Low- and Moderate-intensity Statin and Clinical Outcome of Primary Prevention in Individuals Aged >75 Years: the SCOPE-75 RCT Study
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 aged over 75 years. 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 cardiovascular disease in
elderly individuals.
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 group by 1:1 manner. Blood tests, physical examinations, and evaluation of statin associated muscle symptoms are conducted every 3 months after enrollment. General medical care for prevention of cardiovascular disease is continued after 6 months. The accrual period is 2 years and follow-up period is 4 years, so the total study period is 6 years. ;