Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06676280 | NOT YET RECRUITING | Cardiovascular Diseases

AcetylSalicylic Acid Use for Primary Prevention in Severe Coronary Calcium Score on Computed Tomography
Sponsor:

Jung-min Ahn

Information provided by (Responsible Party):

Jung-min Ahn

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).

Condition or disease

Cardiovascular Diseases

Intervention/treatment

Aspirin

High-intensity statin

Guideline-directed statin therapy

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 5000 participants
Masking : NONE
Primary Purpose : PREVENTION
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)
Actual Study Start Date : 2025-04-28
Estimated Primary Completion Date : 2033-04-28
Estimated Study Completion Date : 2033-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. The subject must be aged between 40 and 75 years.
  • 2. Patients who have coronary artery calcium score ≥400 Agatston Unit on coronary computed tomography angiography.
  • 3. 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. Patients who are symptomatic.
  • 2. Patients who have documented clinical ASCVD: previous myocardial infarction, acute coronary syndrome, stable angina, coronary revascularization and other arterial revascularization procedures, stroke and Transient ischaemic attack, \>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.
  • 6. History of allergy or severe adverse reaction to aspirin or statin
  • 7. History of myositis or myopathy with active disease in the 180 days prior to study entry.
  • 8. Patients who have significantly abnormal findings which identified violation for safety by investigator on physical examination, blood test and electrocardiogram.
  • 9. Concurrent medical condition with a life expectancy of less than 1 years
  • 10. Pregnant and/or lactating women
  • 11. Patient was unable to provide written informed consent or participate in log-term follow up.
AcetylSalicylic Acid Use for Primary Prevention in Severe Coronary Calcium Score on Computed Tomography

Location Details

NCT06676280

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

No Location Found