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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin and High-intensity statin | Experimental | Patients will take aspirin 100 mg/day and high-intensity statin therapy. Statin intensity is defined according to the 2026 ACC/AHA Guideline on the Management of Dyslipidemia |
|
| No aspirin and High-intensity statin | Experimental | Patients will take no aspirin and high-intensity statin therapy. Statin intensity is defined according to the 2026 ACC/AHA Guideline on the Management of Dyslipidemia |
|
| No aspirin and guideline-directed statin | Active Comparator | Patients will take no aspirin and guideline-directed statin therapy. |
|
| Aspirin and guideline-directed statin | Experimental | Patients will take aspirin 100 mg/day and guideline-directed statin therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | Patients will take aspirin 100 mg/day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Event 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 | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Event rate of Each individual component of primary composite outcome | 3 years | |
| Event rate of Death from any causes | 3 years | |
| Event rate of Hospitalization for heart failure |
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Inclusion Criteria:
The subject must be aged between 40 and 75 years.
Patients who have coronary artery calcium score ≥300 Agatston Unit on coronary calcium computed tomography.
Patients who have 1 or more CVD risk factors in below;
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jung-min Ahn, MD | Contact | 82230104728 | drjmahn@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Medical Center | Not yet recruiting | Anyang | South Korea |
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| High-intensity statin | Drug | Statin intensity is defined according to the 2026 ACC/AHA Guideline on the Management of Dyslipidemia |
|
| Guideline-directed statin therapy | Drug | Statin intensity is defined according to the 2026 ACC/AHA Guideline on the Management of Dyslipidemia |
|
| 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. | 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
| 3 years |
| SAM hospital | Not yet recruiting | Anyang | South Korea |
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| Sejong General Hospital | Recruiting | Bucheon-si | South Korea |
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| Dong-A University Hospital | Not yet recruiting | Busan | South Korea |
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| Haeundae paik hospital, inje university | Recruiting | Busan | South Korea |
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| Inje University Busan Paik Hospital | Recruiting | Busan | South Korea |
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| Gyeongsang National University Changwon Hospital | Recruiting | Changwon | South Korea |
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| Chungbuk National University Hospital | Recruiting | Cheonju | South Korea |
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| Hallym University Chuncheon Sacred Heart Hospital | Not yet recruiting | Chuncheon | South Korea |
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| Kangwon National University Hospital | Recruiting | Chuncheon | South Korea |
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| Keimyung University Dongsan Medical Center | Recruiting | Daegu | South Korea |
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| Kyungpook National University Hospital | Recruiting | Daegu | South Korea |
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| Yeungnam University Medical Center | Not yet recruiting | Daegu | South Korea |
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| Chungnam National University Hospital | Recruiting | Daejeon | South Korea |
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| The Catholic University of Korea, Daejeon St. Mary's Hosptial | Recruiting | Daejeon | South Korea |
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| GangNeung Asan Hospital | Recruiting | Gangneung | South Korea |
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| Chonnam National University Hospital | Recruiting | Gwangju | South Korea |
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| Incheon St. Mary's Hospital, The Catholic University of Korea | Not yet recruiting | Incheon | South Korea |
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| Jeonbuk National University Hospital | Recruiting | Jeonju | South Korea |
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| Kwangju Christian Hospital | Not yet recruiting | Kwangju | South Korea |
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| Asan Medical Center | Recruiting | Seoul | South Korea |
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| Hanil General Hospital | Recruiting | Seoul | South Korea |
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| Hanyang University Seoul Hospital | Recruiting | Seoul | South Korea |
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| Kangbuk Samsung Hospital | Not yet recruiting | Seoul | South Korea |
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| Korea University Guro Hospital | Recruiting | Seoul | South Korea |
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| Severance Hospital | Recruiting | Seoul | South Korea |
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| The Catholic University of Korea Seoul St. Mary's Hospital | Not yet recruiting | Seoul | South Korea |
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| The Catholic University of Korea, Eunpyeong St. Mary's Hospitall | Recruiting | Seoul | South Korea |
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| Seoul National University Bundang hospital | Recruiting | Sŏngnam | South Korea |
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| The Catholic University of Korea, Uijeongbu St. Mary's Hospital | Recruiting | Uijeongbu-si | South Korea |
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| Ulsan University Hospital | Recruiting | Ulsan | South Korea |
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| Yongin Severance Hospital | Recruiting | Yongin | South Korea |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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