GUIDE-CAC: Statin-Ezetimibe Without Aspirin vs. Statin Monotherapy With Aspirin in High Coronary Calcification
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorAsan Medical Center
About this trial
A Multicenter, randomized trial comparing the efficacy and safety of intensive lipid-lowering therapy using a statin-ezetimibe combination without aspirin versus statin monotherapy with aspirin in asymptomatic patients with coronary artery calcification
Eligibility criteria
Qualifiers
Adults aged 19 years and older
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
Disqualifiers
Major ASCVD events (clinically documented ASCVD)
Acute coronary syndrome (MI or unstable angina)
Coronary revascularization (PCI, CABG) or other arterial revascularization
Ischemic stroke (Not TIA)
Trial design
Treatments tested in this trial
- Pitavastatin 4mg and ezetimibe 10mg, taken once daily
- Pitavastatin 2 mg with aspirin 100 mg, taken once daily.
Treatment groups
7,435 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov