Camporese Giuseppe, Bernardi Enrico, Bortoluzzi Cristiano, Noventa Franco, Hong Ngoc Vo, Callegari Elena, Villalta Sabina, Tonello Chiara, Nardin Michela, Campello Elena, Spiezia Luca, Simioni Paolo
Unit of Angiology, Department of Cardiac, Thoracic and Vascular Sciences, University Hospital of Padua, Padua, Italy.
Emergency Room, Department of Emergency and Accident Medicine, Conegliano Civic Hospital, Conegliano, Italy.
Front Med (Lausanne). 2021 Jan 28;7:584459. doi: 10.3389/fmed.2020.584459. eCollection 2020.
Real-life studies complement data from registrative trials. Because of the delayed registration of direct oral anticoagulants in Italy, scarce real-life data on such treatments is available for the Italian population. The aim of the MAC project is to collect real-life clinical information in unselected patients given oral anticoagulants for venous thromboembolism, during a 5-year follow-up period. This is a prospective-cohort, multi-center, observational study performed in four Italian centers. The estimated samples size is 4,000 patients. The efficacy outcomes are: incidence of symptomatic recurrent venous thromboembolism and of post-thrombotic syndrome. The safety outcomes are: incidence of major bleeding, clinically relevant non-major bleeding, minor bleeding, serious adverse events, and mortality. The MAC project has the potential to improve our understanding of the epidemiology and of the therapeutic strategies adopted in Italian patients with venous thromboembolism. : WWW.ClinicalTrials.Gov, identifier: NCT0432939.
真实世界研究补充了注册试验的数据。由于意大利直接口服抗凝剂的注册延迟，该国人群中关于此类治疗的真实世界数据稀缺。MAC项目的目的是在5年随访期内，收集接受口服抗凝剂治疗静脉血栓栓塞的未选择患者的真实世界临床信息。这是一项在意大利四个中心进行的前瞻性队列、多中心观察性研究。估计样本量为4000名患者。疗效指标包括：有症状的复发性静脉血栓栓塞和血栓后综合征的发生率。安全性指标包括：大出血、临床相关非大出血、小出血、严重不良事件和死亡率的发生率。MAC项目有可能增进我们对意大利静脉血栓栓塞患者的流行病学和治疗策略的了解。：WWW.ClinicalTrials.Gov，标识符：NCT0432939
