Clinical trial NCT06676280: ASpirin Use and stAtin Strategy for Primary Prevention in Severe Coronary Calcium Score on Computed Tomography
Official title: an Investigator-initiated, Multicenter, Open-label, 2-by-2 Factorial, and Randomized Trial to Evaluate the Role of Aspirin and High-intensity Statin Therapy, Respectively, in Individuals With Severe Coronary Calcification (Coronary Calcium Score ≥400) to Prevent Atherosclerotic Cardiovascular Disease (ASCVD) Events With Severe Coronary Calcification (CAC ≥400)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Cardiovascular Diseases
Keywords: atherosclerotic cardiovascular disease
aspirin
high-intensity statin
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 5000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: 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 ≥400) to prevent atherosclerotic cardiovascular disease (ASCVD) events with severe coronary calcification (CAC ≥400).


Eligibility criteria: Inclusion Criteria:

1. The subject must be aged between 40 and 70 years.
2. Patients who have coronary artery calcium score ≥400 Agatston Unit on coronary calcium computed tomography.
3. Patients who have 1 or more CVD risk factors in below;

   * dyslipidemia or,
   * diabetes or,
   * hypertension or,
   * family history of CVD or,
   * smoking
4. Patients agree to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

1. Individuals who have symptomatic coronary artery disease or heart failure.
2. Patients who have documented clinical Atherosclerotic Cardiovascular Disease: previous myocardial infarction, acute coronary syndrome, stable angina, coronary revascularization and other arterial revascularization procedures, stroke and Transient ischaemic attack (TIA), \>50% carotid stenosis or previous carotid endarterectomy or stenting, aortic aneurysm and peripheral artery disease.
3. Patients who have evidence of myocardial ischemia on non-invasive stress test including stress single photon emission CT myocardial perfusion imaging (SPECT MPI), cardiovascular magnetic resonance (CMR) imaging, stress echocardiography, or treadmill test, or on invasive stress test including Fractional flow reserve (FFR) \< 0.80 on invasive coronary angiography (diameter stenosis\>50% without objective evidence of ischemia could be enrolled).
4. Patients at high risk of bleeding: gastrointestinal hemorrhage or peptic ulcer within the previous 6 months; active hepatic disease such as cirrhosis or active hepatitis; use of warfarin, or other anticoagulant therapy; or has a history of aspirin allergy.
5. Patients with atrial fibrillation and flutter.
6. Patients with severe left ventricular dysfunction (ejection fraction ≤30%) or severe valvular heart disease who experience dyspnea on exertion (The NYHA (New York Heart Association) Functional Classification III-IV).
7. History of allergy or severe adverse reaction to aspirin or statin or ezetimibe.
8. History of myositis or myopathy with active disease in the 180 days prior to study entry.
9. Patients with active liver disease or persistent unexplained serum transaminase elevation.
10. Patients who have significantly abnormal findings which identified violation for safety by investigator on physical examination, blood test and electrocardiogram.
11. History of alcohol or drug abuse.
12. Concurrent medical condition with a life expectancy of less than 1 years.
13. Pregnant and/or lactating women.
14. Patient was unable to provide written informed consent or participate in log-term follow up.

Primary outcomes:
measure: Event rate of a composite of atherosclerotic cardiovascular disease event
timeFrame: 3 years
Secondary outcomes:
measure: Event rate of Each individual component of primary composite outcome
timeFrame: 3 years
measure: Event rate of Death from any causes
timeFrame: 3 years
measure: Event rate of Hospitalization for heart failure
timeFrame: 3 years
measure: Event rate of the first occurrence of any major bleeding
timeFrame: 3 years
measure: Event rate of the Safety secondary endpoint
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References: