Antithrombotic Therapy in Acute Coronary Syndromes and Coronary Artery Ectasia
Status:
Recruiting
Trial end date:
2024-07-30
Target enrollment:
Participant gender:
Summary
The optimal anti-thrombotic therapy to prevent recurrent ischemic events in patients with
acute coronary syndrome and coronary artery ectasia (CAE) remains unclear.
OVER-TIME is an investigator initiated, exploratory, open label, single center, randomized
clinical trial comparing dual antiplatelet therapy (acetyl-salicylic acid plus a P2Y12
inhibitor) with the combination of an antiplatelet monotherapy (a P2Y12 inhibitor) plus a low
dose anticoagulant (rivaroxaban, 15mg oral dose) for the prevention of recurrent ischemic
events among patients with CAE. The investigators aim to enroll 60 patients with CAE and
acute coronary syndromes. After recruitment, patients are randomized to (a) standard of care
(dual antiplatelet regimen) or (b) the combination of antiplatelet monotherapy and low dose
anticoagulant. Patients will be followed for at least 12 months. The OVER-TIME study aims to
assess the efficacy of the regimen in prevention of major cardiovascular events and its
security in bleeding events in acute coronary syndromes among patients with CAE.
OVER-TIME is the first randomized controlled trial to assess different antithrombotic
strategies in patients with CAE and acute coronary syndrome, and its results will offer
preliminary data for the prevention of major cardiovascular events and bleeding events in
this group of patients.