Masuda Shinichiro, Muramatsu Takashi, Ishibashi Yuki, Kozuma Ken, Tanabe Kengo, Nakatani Shimpei, Kogame Norihiro, Nakamura Masato, Asano Taku, Okamura Takayuki, Miyazaki Yosuke, Tateishi Hiroki, Ozaki Yukio, Nakazawa Gaku, Morino Yoshihiro, Katagiri Yuki, Garg Scot, Hara Hironori, Ono Masafumi, Kawashima Hideyuki, Lemos Pedro A, Serruys Patrick W, Onuma Yoshinobu
Department of Cardiology, National University of Ireland Galway (NUIG), Galway, Ireland.
Department of Cardiology, Fujita Health University Hospital, Toyoake, Japan.
AsiaIntervention. 2023 Mar 15;9(1):39-48. doi: 10.4244/AIJ-D-22-00033. eCollection 2023 Mar.
The Acetyl Salicylic Elimination Trial (ASET) Japan pilot study is a multicentre, single-arm, open-label, proof-of-concept study with a stopping rule based on the occurrence of definite stent thrombosis. This study aims to demonstrate the feasibility and safety of low-dose prasugrel monotherapy following percutaneous coronary intervention (PCI) in Japanese patients presenting with chronic coronary syndromes (CCS) or non-ST-elevation acute coronary syndromes (NSTE-ACS). Four hundred patients with a SYNTAX score <23 requiring PCI due to CCS or NSTE-ACS will be screened and considered eligible for the study. The enrolment is planned in two phases: 1) 200 patients presenting with CCS, followed by 2) 200 patients presenting with NSTE-ACS. After optimal PCI with implantation of a SYNERGY (Boston Scientific) stent, patients will be enrolled and loaded with prasugrel 20 mg, followed by a maintenance dose of prasugrel 3.75 mg once daily without aspirin continued for 3 months in Phase 1 (CCS patients), and for 12 months in Phase 2 (NSTE-ACS patients). After these follow-up periods, prasugrel will be replaced by standard antiplatelet therapy according to local practice. The primary endpoint is a composite of cardiac death, target vessel myocardial infarction, or definite stent thrombosis after the index procedure. The primary bleeding endpoint is any Bleeding Academic Research Consortium type 3 or 5 bleeding occurring within 3 months of the index PCI for CCS patients, or 12 months for NSTE-ACS patients. The ASET Japan study is designed to demonstrate the feasibility and safety of reduced-dose prasugrel monotherapy after PCI in East Asian patients with acute and chronic coronary syndromes.
乙酰水杨酸消除试验（ASET）日本试点研究是一项多中心、单臂、开放标签的概念验证研究，设有基于明确支架血栓形成情况的终止规则。本研究旨在证明在患有慢性冠状动脉综合征（CCS）或非ST段抬高急性冠状动脉综合征（NSTE-ACS）的日本患者经皮冠状动脉介入治疗（PCI）后，低剂量普拉格雷单药治疗的可行性和安全性。将筛选400例因CCS或NSTE-ACS而SYNTAX评分<23且需要PCI的患者，并认为其符合研究条件。招募计划分两个阶段进行：1）200例患有CCS的患者，随后2）200例患有NSTE-ACS的患者。在使用SYNERGY（波士顿科学公司）支架进行最佳PCI后，患者将入组并服用20 mg普拉格雷进行负荷给药，随后在第1阶段（CCS患者）维持剂量为每日一次3.75 mg普拉格雷且不继续使用阿司匹林，持续3个月，在第2阶段（NSTE-ACS患者）持续12个月。在这些随访期后，将根据当地实践将普拉格雷替换为标准抗血小板治疗。主要终点是首次手术后的心源性死亡、靶血管心肌梗死或明确的支架血栓形成的复合终点。主要出血终点是CCS患者在首次PCI后3个月内或NSTE-ACS患者在12个月内发生的任何出血学术研究联盟3型或5型出血。ASET日本研究旨在证明在东亚急性和慢性冠状动脉综合征患者PCI后降低剂量普拉格雷单药治疗的可行性和安全性。
