The primary objective of the ASA-3C trial is to evaluate the role of aspirin and high-intensity statin therapy, respectively, in individuals with severe coronary calcification (coronary calcium score ≥300) to prevent atherosclerotic cardiovascular disease (ASCVD) events with severe coronary calcification (CAC ≥300).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
5,000
Patients will take aspirin 100 mg/day.
Statin intensity is defined as 2018 Cholesterol Clinical Practice Guidelines.
as 2018 Cholesterol Clinical Practice Guidelines.
Asan Medical Center
Seoul, South Korea
RECRUITINGEvent rate of a composite of atherosclerotic cardiovascular disease event
cardiovascular death; myocardial infarction ; hospitalization for Acute coronary syndrome; stroke; Transient ischaemic attack; peripheral arterial ischemia ;revascularization of coronary, carotid, or peripheral artery ;or death from an undetermined cause
Time frame: 3 years
Event rate of Each individual component of primary composite outcome
Time frame: 3 years
Event rate of Death from any causes
Time frame: 3 years
Event rate of Hospitalization for heart failure
Time frame: 3 years
Event rate of the first occurrence of any major bleeding
\[Safety secondary endpoint\] major bleeding is defined as a composite of intracranial hemorrhage, site-threatening bleeding event in the eye, gastrointestinal bleeding, or any other serious bleeding that resulted in hospitalization, transfusion, or that was fatal.
Time frame: 3 years
Event rate of the Safety secondary endpoint
Safety secondary endpoint: Aspirin the first occurrence of any major bleeding; a composite of intracranial hemorrhage, site-threatening bleeding event in the eye, gastrointestinal bleeding, or any other serious bleeding that resulted in hospitalization, transfusion, or that was fatal. Statin * Muscle related adverse events; myalgia, myositis, myopathy, myonecrosis, rhabdomyolysis * New onset diabetes mellitus * Gall bladder-related adverse events * Cancer diagnosis * Cataract operation * New-onset neurocognitive disorder * Discontinuation or dose-reduction of statin therapy by intolerance
Time frame: 3 years
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