Acetyl Salicylic Elimination Trial JAPAN: The ASET JAPAN Pilot Study

Summary

The ASET Japan Pilot study is a multicenter, single arm, open-label trial of single antiplatelet therapy with prasugrel for patients undergoing successful and optimal Percutaneous Coronary Intervention (PCI) for Chronic Coronary Syndrome (CCS) and Non-ST elevation Acute coronary syndrome (NSTE-ACS). The enrollment consists of two phases: i) 200 patients presenting with CCS; ii) 200 patients presenting with NSTE-ACS. The patients will be loaded with standard dual antiplatelet therapy according to local practice (usually aspirin 81 to 330 mg and clopidogrel 300 mg or prasugrel 20 mg or ticagrelor 180 mg, unless patient is on long-term therapy) prior to the PCI procedure. After PCI, if the results are considered to be satisfactory by the operator based on clinical (e.g. clinical status, ECG, etc.), angiographic and/or findings from intracoronary imaging, only then patients will be enrolled in the study and loaded with prasugrel 20 mg if the patients have not loaded prasugrel prior to PCI or have not taken a maintenance dose of prasugrel before the index PCI. Patients continued with prasugrel only (3.75 mg once a day) for three months in CCS patients and for 12 months in NSTE-ACS patients. Aspirin, clopidogrel, and ticagrelor will be discontinued just after the index procedure. i. CCS patients (phase 1): At the 3-months follow-up visit, prasugrel monotherapy will be replaced by aspirin monotherapy or dual-antiplatelet therapy according to local standard of care. Clinical follow-up with office visit will be performed at 3 months and telephone contacts at 1, and 4 months (final follow-up). ii. NSTE-ACS patients (phase 2): At the 12-months follow-up visit, prasugrel monotherapy will be replaced by aspirin monotherapy for an observational period of 1 month, followed by antiplatelet treatment according to local practice. Clinical follow-up with office visit will be performed at 1 and 12 months and telephone contacts at 3, 6, 9 and 13 months (final follow-up). All events will be adjudicated by an independent clinical events committee (CEC). An independent Data Safety and Monitoring Board (DSMB) will monitor the individual and collective safety of the patients in the study during enrolment of CCS patients and up to 3 months follow-up of CCS patients, and during enrollment of NSTE-ACS patients and up to 12 months follow-up of NSTE-ACS patients (timepoint for primary endpoint).

Timeline

Start

2020-09-15

Primary completion

2024-07-31

Completion

2025-12-31

Publications

• Background Masuda S, Muramatsu T, Ishibashi Y, Kozuma K, Tanabe K, Nakatani S, Kogame N, Nakamura M, Asano T, Okamura T, Miyazaki Y, Tateishi H, Ozaki Y, Nakazawa G, Morino Y, Katagiri Y, Garg S, Hara H, Ono M, Kawashima H, Lemos PA, Serruys PW, Onuma Y. Reduced-dose prasugrel monotherapy without aspirin after PCI with the SYNERGY stent in East Asian patients presenting with chronic coronary syndromes or non-ST-elevation acute coronary syndromes: rationale and design of the ASET Japan pilot study. AsiaIntervention. 2023 Mar 15;9(1):39-48. doi: 10.4244/AIJ-D-22-00033. eCollection 2023 Mar.
• Results Muramatsu T, Masuda S, Kotoku N, Kozuma K, Kawashima H, Ishibashi Y, Nakazawa G, Takahashi K, Okamura T, Miyazaki Y, Tateishi H, Nakamura M, Kogame N, Asano T, Nakatani S, Morino Y, Katagiri Y, Ninomiya K, Kageyama S, Takahashi H, Garg S, Tu S, Tanabe K, Ozaki Y, Serruys PW, Onuma Y. Prasugrel Monotherapy After Percutaneous Coronary Intervention With Biodegradable-Polymer Platinum-Chromium Everolimus Eluting Stent for Japanese Patients With Chronic Coronary Syndrome (ASET-JAPAN). Circ J. 2023 May 25;87(6):857-865. doi: 10.1253/circj.CJ-23-0051. Epub 2023 Mar 11.
• Results Masuda S, Tanabe K, Guimaraes PO, Muramatsu T, Ozaki Y, De Martino F, Kozuma K, Garg S, Kotoku N, Ninomiya K, Kageyama S, Lemos PA, Onuma Y, Serruys PW. Prasugrel Monotherapy After Percutaneous Coronary Intervention for Chronic Coronary Syndrome: Insights From ASET Pilot Studies. JACC Asia. 2023 Dec 12;4(3):171-182. doi: 10.1016/j.jacasi.2023.10.007. eCollection 2024 Mar.
• Results Kotoku N, Ninomiya K, Masuda S, Tsai TY, Revaiah PC, Garg S, Kageyama S, Tu S, Kozuma K, Kawashima H, Ishibashi Y, Nakazawa G, Takahashi K, Okamura T, Miyazaki Y, Tateishi H, Nakamura M, Kogame N, Asano T, Nakatani S, Morino Y, Ishida M, Katagiri Y, De Martino F, Tinoco J, Guimaraes PO, Tanabe K, Ozaki Y, Muramatsu T, Lemos PA, Onuma Y, Serruys PW; ASET Japan and ASET Brazil Investigators. Geographic disparity of pathophysiological coronary artery disease characteristics: Insights from ASET trials. Int J Cardiol. 2024 Apr 1;400:131805. doi: 10.1016/j.ijcard.2024.131805. Epub 2024 Jan 23.
• Results Kotoku N, Ninomiya K, Masuda S, O'Leary N, Garg S, Naito M, Miyashita K, Tobe A, Kageyama S, Tsai TY, Revaiah PC, Tu S, Kozuma K, Kawashima H, Ishibashi Y, Nakazawa G, Takahashi K, Okamura T, Miyazaki Y, Tateishi H, Nakamura M, Kogame N, Asano T, Nakatani S, Morino Y, Ishida M, Katagiri Y, Ono M, Hara H, Sotomi Y, Tanabe K, Ozaki Y, Muramatsu T, Dijkstra J, Onuma Y, Serruys PW. Preprocedural physiological assessment of coronary disease patterns to predict haemodynamic outcomes post-PCI. EuroIntervention. 2023 Dec 18;19(11):e891-e902. doi: 10.4244/EIJ-D-23-00516.
• Miyashita K, Onuma Y, Bianchini E, Muramatsu T, Nakazawa G, Ishibashi Y, Kozuma K, Asano T, Katagiri Y, Okamura T, Morino Y, Kogame N, Ono M, Miyazaki Y, Nakatani S, Nakamura M, Tobe A, Oshima A, Tsai TY, Garg S, Tanabe K, Ozaki Y, Spertus JA, Serruys PW. Impact of Angiography-Derived Physiological Patterns of CAD and Optimal Hemodynamics Post-PCI on Residual Angina. JACC Asia. 2026 Jul;6(7):1108-1118. doi: 10.1016/j.jacasi.2026.03.023. Epub 2026 May 16.
• Revaiah PC, Miyashita K, Tsai TY, Bajaj R, Kotoku N, Tobe A, Muramatsu T, Tanabe K, Kozuma K, Ozaki Y, Garg S, Tu S, Dijkstra J, Bourantas CV, Onuma Y, Serruys PW. Segmental post-percutaneous coronary intervention physiological gradients using ultrasonic or optical flow ratio: insights from ASET JAPAN study. Eur Heart J Imaging Methods Pract. 2025 Jan 30;3(1):qyaf017. doi: 10.1093/ehjimp/qyaf017. eCollection 2025 Jan.
• He X, Tsung-Ying T, Revaiah PC, Wykrzykowska JJ, Rosseel L, Sharif F, Muramatsu T, Reiber JH, Garg S, Miyashita K, Tobe A, Tao L, Onuma Y, Serruys PW. Nomogram based on virtual hyperemic pullback pressure gradients for predicting the suboptimal post-PCI QFR outcome after stent implantation. Int J Cardiovasc Imaging. 2024 Dec;40(12):2469-2479. doi: 10.1007/s10554-024-03253-1. Epub 2024 Oct 12.

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