Statin plus ezetimibe without aspirin versus statin with aspirin for people with high coronary calcium

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized Phase 4 trial enrolls asymptomatic adults with significant coronary artery calcification (Agatston score ≥100) and no physiologically significant coronary artery disease to compare two prevention strategies. One group receives pitavastatin 4 mg plus ezetimibe 10 mg daily without aspirin, and the other receives pitavastatin 2 mg plus aspirin 100 mg daily. The study measures cardiovascular events and safety outcomes, including bleeding, over follow-up to determine if the intensive lipid-lowering approach without aspirin is non-inferior to the statin-plus-aspirin strategy. The design aims to balance efficacy in preventing events against the harms of routine aspirin use in primary prevention.

Why it matters

Who can join: the full rules

Inclusion Criteria

1. Adults aged 19 years and older
2. Asymptomatic patients with significant coronary calcification (Agatston score ≥ 100) and no physiologically significant coronary artery disease (CAD)

   * The coronary CT scan used to establish the CAC score must be performed within 3 years prior to randomization.
   * The assessment of physiological significance must be performed within 6 months prior to randomization
3. Participants will be eligible for inclusion regardless of prior statin or anti-platelet agents use.

Exclusion Criteria

1. Major ASCVD events (clinically documented ASCVD)

   If at least one of the following criteria is present via patient history, physical examination, or medical records at the time of screening, the patient is not eligible:
   * Acute coronary syndrome (MI or unstable angina)
   * Coronary revascularization (PCI, CABG) or other arterial revascularization
   * Ischemic stroke (Not TIA)
   * Symptomatic peripheral arterial disease (history of claudication with ABI \<0.90, or previous revascularization or amputation
2. Patients with physiologically significant CAD

   * Moderate to severe CAD (diameter stenosis \>50%) on CCTA with positive strest test (thallium, treadmil, stress echocardiography)
   * Moderate to severe CAD (diameter stenosis \>50%) on CAG with positive fractional flow reserve (FFR) \< 0.8
3. Patients with familial hypercholesterolemia.
4. Patients with low-density lipoproteins cholesterol (LDL-C) ≥ 190 mg/dL regardless taking a statin or not.
5. Continuation of PCSK9 inhibitor is required during the clinical trial
6. Patients with chronic kidney disease (\<eGFR 30mL/min/1.73m2)
7. Advanced liver disease (Child-Pugh B or C)
8. Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST \> 5 times upper limit of normal).
9. History of gastrointestinal bleeding, peptic ulcer, or intracranial hemorrhage within 6 months prior screening
10. Patients with a history of organ transplantation who are on immunosuppressive therapy
11. Concurrent use of other medications that may increase bleeding risk such NOAC and warfarin
12. A history of significant allergic reaction to aspirin or statin/ezetimibe
13. A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer.
14. Life expectancy \< 1 years for any non-cardiac or cardiac causes.
15. Patient's pregnant or breast-feeding or child-bearing potential.
16. Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
17. Unwillingness or inability to comply with the procedures described in this protocol

Where it's running

• Asan Medical Center
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Seung-Whan Lee
• Email: seungwlee@amc.seoul.kr
• Phone: 82230103170

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Bringing preventive cardiovascular care to Indigenous and remote communities

  This project tests a mobile health unit to screen and provide culturally safe cardiovascular and metabolic care for Indigenous and remote communities in Canada.

  Recruiting Laval University · Québec, Quebec · NCT07869069

• Intensive versus standard care and education for cholesterol management in people with hypertension and diabetes

  This project will test whether a structured, intensive dyslipidemia management and education program helps adults with hypertension and diabetes improve their blood lipid levels.

  Recruiting Saint Vincent's Hospital, Korea · Gyeonggi-do, Suwon-si · NCT07045623

• Optimizing LDL cholesterol levels using inclisiran for patients with drug interactions

  This study is testing if inclisiran can help lower LDL cholesterol in patients with multiple health issues who can't take statins due to other medications.

  Recruiting Phase 4 University of California, San Diego · La Jolla, California · NCT06865885

• Comparison of low-dose rosuvastatin with ezetimibe versus high-dose rosuvastatin for coronary artery disease

  This study is testing whether a low-dose combination of rosuvastatin and ezetimibe can help people with coronary artery disease just as well as high-dose rosuvastatin alone, while also looking for fewer side effects.

  Recruiting Phase 4 Saint Vincent's Hospital, Korea · Suwon, Gyeonggi-do · NCT06186037

• Preventing postoperative delirium in frail elderly patients undergoing elective surgery

  This study is testing whether special care from nurses can help frail elderly patients avoid confusion after surgery compared to regular care.

  Recruiting Pontificia Universidad Catolica de Chile · Santiago, Santiago Metropolitan · NCT05993754

• Comparing Taurolidine and Saline Locks for Catheter Care in Children with Cancer

  This study tests whether using a Taurolidine lock instead of a regular saline lock can help prevent infections in central catheters for kids and young adults with cancer.

  Recruiting at 5 sites Institut Curie · Paris and 4 other locations · NCT05781295

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.