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.