Araiza-Garaygordobil Diego, Gopar-Nieto Rodrigo, Sierra-Lara Martínez Daniel, Belderrain-Morales Nallely, Sarabia-Chao Vianney, Alfaro-Ponce Diana Laura, Ontiveros-Mercado Heriberto, Mendoza-García Salvador, Altamirano-Castillo Alfredo, Martinez-Amezcua Pablo, Cabello-López Alejandro, Briseño-De la Cruz Jose Luis, Ruiz-Beltrán Maximiliano, Martínez-Ríos Marco Antonio, Piña-Reyna Yigal, Gonzalez-Pacheco Hector, Arias-Mendoza Alexandra
Coronary Care Unit, National Institute of Cardiology "Ignacio Chávez", Juan Badiano 1, Belisario Dominguez Sección XVI, Tlalpan, 14030, Mexico City, Mexico.
Division of General Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, USA.
High Blood Press Cardiovasc Prev. 2022 Sep;29(5):463-468. doi: 10.1007/s40292-022-00535-4. Epub 2022 Jul 29.
The optimal anti-thrombotic therapy to prevent recurrent ischemic events in patients with acute coronary syndrome and coronary artery ectasia (CAE) remains unclear.
To assess the efficacy and safety of antiplatelet plus anticoagulant therapy versus dual antiplatelet therapy in patients with acute coronary syndromes and coronary artery ectasia.
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. We aim to enroll approximately 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. Expected results and conclusions: 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.
NCT05233124 (ClinicalTrials.gov), date of registration: February 10, 2022.
对于急性冠状动脉综合征和冠状动脉扩张（CAE）患者，预防复发性缺血事件的最佳抗血栓治疗方案仍不明确。
评估抗血小板加抗凝治疗与双联抗血小板治疗对急性冠状动脉综合征和冠状动脉扩张患者的疗效和安全性。
“超时间”（OVER-TIME）是一项由研究者发起的、探索性的、开放标签的、单中心随机临床试验，比较双联抗血小板治疗（乙酰水杨酸加一种P2Y12抑制剂）与抗血小板单药治疗（一种P2Y12抑制剂）加低剂量抗凝剂（利伐沙班，口服剂量15mg）联合使用，以预防CAE患者复发性缺血事件。我们的目标是招募约60例患有CAE和急性冠状动脉综合征的患者。招募后，患者被随机分为（a）标准治疗（双联抗血小板方案）或（b）抗血小板单药治疗与低剂量抗凝剂联合使用组。患者将接受至少12个月的随访。“超时间”研究旨在评估该方案在预防CAE患者急性冠状动脉综合征主要心血管事件方面的疗效及其在出血事件中的安全性。预期结果和结论：“超时间”是第一项评估CAE和急性冠状动脉综合征患者不同抗血栓策略的随机对照试验，其结果将为预防该组患者的主要心血管事件和出血事件提供初步数据。
NCT05233124（ClinicalTrials.gov），注册日期：2022年2月10日。
