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GUIDE-CAC: Statin-Ezetimibe Without Aspirin vs. Statin Monotherapy With Aspirin in High Coronary Calcification

ConditionsPrimary PreventionVascular 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Pitavastatin 4mg and ezetimibe 10mg, taken once daily

    Drug

    Intensive lipid-lowering therapy without aspirin

  • Pitavastatin 2 mg with aspirin 100 mg, taken once daily.

    Drug

    Moderate-intensity lipid-lowering therapy with aspirin

Treatment groups

7,435 Participants
are divided into 2 treatment groups
Group A: Intensive lipid-lowering therapy without aspirinExperimental treatment 1 intervention
Group B: Statin Monotherapy with AspirinActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Event rate of a major adverse cardiovascular events

Death from any cause, myocardial infarction, stroke, urgent coronary revascularization, resuscitated cardiac arrest, or unstable angina related hospitalization

Time frame
48months

Secondary outcomes

1

Event rate of a all cause death

All-cause mortality was used instead of cardiac mortality to avoid potentially difficult adjudication of causes of death, especially given the relatively low expected mortality rate. In addition, the cause of death will be adjudicated as being due to cardiovascular causes, non-cardiovascular causes, or undetermined causes.

Time frame
48months
2

Event rate of a cardiovascular death

includes death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure (HF), death due to stroke, death due to cardiovascular (CV) procedures, death due to CV hemorrhage, and death due to other CV causes

Time frame
48months
3

Event rate of a spontaneous myocardial infarction

A spontaneous myocardial infarction related to atherosclerotic plaque rupture, ulceration, fissuring, erosion, or dissection, resulting in intraluminal thrombus in one or more of the coronary arteries

Time frame
48months
4

Event rate of a stroke

A. Ischemic Stroke B. Hemorrhagic Stroke C. Undetermined Stroke

Time frame
48months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Asan Medical Center

Lead sponsor

Source ClinicalTrials.gov
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