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Prevention study for Cardiovascular Diseases
Official title ASpirin Use and stAtin Strategy for Primary Prevention in Severe Coronary Calcium Score on Computed Tomography
ClinicalTrials.gov ID: NCT06676280
What this study is testing
What is Aspirin?
Aspirin is an investigational medicine, being studied as a potential treatment for cardiovascular diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 75
You may be able to join if
- 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;
- dyslipidemia or,
- diabetes or,
You likely can't join if
- Individuals who have symptomatic coronary artery disease or heart failure.
- Patients who have documented clinical Atherosclerotic Cardiovascular Disease: previous myocardial infarction, acute coronary syndrome, stable angina...
- Patients who have evidence of myocardial ischemia on non-invasive stress test including stress single photon emission CT myocardial perfusion imaging...
- Patients at high risk of bleeding: gastrointestinal hemorrhage or peptic ulcer within the previous 6 months; active hepatic disease such as cirrhosis...
- Patients with atrial fibrillation and flutter.
- Patients with severe left ventricular dysfunction (ejection fraction ≤30%) or severe valvular heart disease who experience dyspnea on exertion (The...
See the full eligibility 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;
- dyslipidemia or,
- diabetes or,
- hypertension or,
- family history of CVD or,
- smoking
- 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...
- Individuals who have symptomatic coronary artery disease or heart failure.
- Patients who have documented clinical Atherosclerotic Cardiovascular Disease: previous myocardial infarction, acute coronary syndrome, stable angina, coronary revascularization and other arterial revascularization...
- 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...
- 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...
- Patients with atrial fibrillation and flutter.
- 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).
- History of allergy or severe adverse reaction to aspirin or statin or ezetimibe.
- History of myositis or myopathy with active disease in the 180 days prior to study entry.
- Patients with active liver disease or persistent unexplained serum transaminase elevation.
- Patients who have significantly abnormal findings which identified violation for safety by investigator on physical examination, blood test and electrocardiogram.
- History of alcohol or drug abuse.
- Concurrent medical condition with a life expectancy of less than 1 years.
- Pregnant and/or lactating women.
- Patient was unable to provide written informed consent or participate in log-term follow up.
The study team makes the final eligibility decision.
Where it's taking place
- Anyang, South Korea
- Bucheon-si, South Korea
- Busan, South Korea
- Changwon, South Korea
- Cheonju, South Korea
- Chuncheon, South Korea
- Daegu, South Korea
- Daejeon, South Korea
- Gangneung, South Korea
- Gwangju, South Korea
- Incheon, South Korea
- Jeonju, South Korea
- Kwangju, South Korea
- Seoul, South Korea
- Sŏngnam, South Korea
- Uijeongbu-si, South Korea
- Ulsan, South Korea
- Yongin, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anyang, South Korea; Bucheon-si, South Korea; Busan, South Korea; Changwon, South Korea; Cheonju, South Korea; Chuncheon, South Korea and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.