ASpirin Use and stAtin Strategy for Primary Prevention in Severe Coronary Calcium Score on Computed Tomography

Phase 4

Not yet recruiting

• Conditions: Cardiovascular Diseases
• Interventions: Drug: Aspirin; Drug: Guideline-directed statin therapy; Drug: High-intensity statin

• Registration Number: NCT06676280
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-04
• Study First Submitted QC: 2024-11-04
• Study First Posted: 2024-11-06
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04
• Study Start: 2025-04-28
• Primary Completion: 2033-04-28
• Study Completion: 2033-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 5000

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. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Aspirin and High-intensity statin	Aspirin	Patients will take aspirin 100 mg/day and high-intensity statin therapy. Statin intensity is defined as 2018 Cholesterol Clinical Practice Guidelines.
Aspirin and High-intensity statin	High-intensity statin	Patients will take aspirin 100 mg/day and high-intensity statin therapy. Statin intensity is defined as 2018 Cholesterol Clinical Practice Guidelines.
No aspirin and High-intensity statin	High-intensity statin	Patients will take no aspirin and high-intensity statin therapy. Statin intensity is defined as 2018 Cholesterol Clinical Practice Guidelines.
No aspirin and guideline-directed statin	Guideline-directed statin therapy	Patients will take no aspirin and guideline-directed statin therapy.
Aspirin and guideline-directed statin	Aspirin	Patients will take aspirin 100 mg/day and guideline-directed statin therapy.
Aspirin and guideline-directed statin	Guideline-directed statin therapy	Patients will take aspirin 100 mg/day and guideline-directed statin therapy.

Primary Outcome Measures

Name	Time	Method
Event rate of a composite of atherosclerotic cardiovascular disease event	5years	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

Secondary Outcome Measures

Name	Time	Method
Event rate of Each individual component of primary composite outcome	5years
Event rate of Death from any causes	5years
Event rate of Hospitalization for heart failure	5years
Event rate of the first occurrence of any major bleeding	5years	\[Safety secondary endpoint\] 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.
Event rate of the Safety secondary endpoint	5years	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 Myalgia, Myositis, Myopathy, Rhabdomyolysis, statin associated auto immune myopathy, New-onset diabetes mellitus.