Coronary artery ectasia (CAE) is a condition in which a coronary artery becomes abnormally dilated, measuring at least 50% larger than the adjacent normal segment. Although relatively uncommon, CAE is clinically important because it can lead to abnormal blood flow and increase the risk of blood clot formation. Patients with CAE are at higher risk of angina, myocardial infarction, and complications during coronary interventions. Despite these risks, the optimal antithrombotic treatment for patients with acute coronary syndrome (ACS) and CAE remains uncertain.
Dual antiplatelet therapy (aspirin plus clopidogrel) is currently the most commonly used treatment. However, the abnormal blood flow patterns observed in CAE may promote clot formation through mechanisms that could potentially be better addressed with anticoagulant therapy.
The OVER-TIME II trial is a multicenter randomized clinical trial designed to compare two antithrombotic strategies in patients with ACS and CAE: standard dual antiplatelet therapy versus antiplatelet monotherapy combined with anticoagulation. The study aims to determine whether the addition of anticoagulation reduces major cardiovascular events without significantly increasing bleeding risk.
Adults aged 18 to 80 years, of either sex, hospitalized with acute coronary syndrome (ACS) with or without ST-segment elevation.
Clinical presentation consistent with acute coronary syndrome.
Elevated high-sensitivity cardiac troponin above the 99th percentile.
Presence or absence of persistent ST-segment elevation.
Pregnant women.
Current indication for temporary or long-term anticoagulation therapy at the time of enrollment.
Severe chronic kidney disease, defined as KDIGO stage G4 or higher (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m²).
Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m² at hospital discharge.
Parallel
Aspirin 100 mg
DrugParticipants receive aspirin 100 mg once daily
Clopidogrel 75 mg
DrugParticipants receive clopidogrel 75 mg once daily
Rivaroxaban 15 mg
DrugParticipants receive oral anticoagulation using rivaroxaban 15 mg once daily
Time to First Major Adverse Cardiovascular Event (MACE)
Time to first occurrence of the composite of cardiovascular death, non-fatal myocardial infarction, or repeat coronary revascularization in patients with coronary artery ectasia following acute coronary syndrome, according to the assigned antithrombotic treatment strategy (dual antiplatelet therapy versus clopidogrel plus rivaroxaban).
Time to First Bleeding Event According to the BARC Classification
Time to first occurrence of a composite of major or minor bleeding events defined according to the Bleeding Academic Research Consortium (BARC) classification in patients with coronary artery ectasia following acute coronary syndrome, according to the assigned antithrombotic treatment strategy (dual antiplatelet therapy versus clopidogrel plus rivaroxaban).
Individual Components of the Major Adverse Cardiovascular Event Composite
Incidence of each individual component of the primary efficacy composite endpoint (cardiovascular death, non-fatal myocardial infarction, and repeat coronary revascularization) in patients with coronary artery ectasia following acute coronary syndrome, according to the assigned antithrombotic treatment strategy.
Individual Bleeding Events According to the BARC Classification
Incidence of individual bleeding events according to the Bleeding Academic Research Consortium (BARC) classification in patients with coronary artery ectasia following acute coronary syndrome, according to the assigned antithrombotic treatment strategy.
Genetic Variants and Gene Expression Profiles Associated With Coronary Artery Ectasia and Treatment Response
Analysis of genetic variants and gene expression profiles, including DNA, RNA and circulating microRNA obtained from peripheral blood samples collected at randomization and at 12 months of follow-up. These analyses aim to identify molecular signatures associated with susceptibility to coronary artery ectasia, disease progression, and differential response to antithrombotic therapy. This exploratory analysis will be performed in an approximately 30% subset of the study population.
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