Acetyl Salicylic Elimination Trial JAPAN: The ASET JAPAN Pilot Study

NCT05117866 | Active Not Recruiting DMC

• 1 other identifier: CR20-023
• Study Type: interventional
• Target: 307
• Locations: 2 countries
• Sites: 13

Brief 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).

Conditions

Chronic Coronary Syndrome; Non ST Segment Elevation Acute Coronary Syndrome

Keywords

prasugrel monotherapy

Outcome Measures

Primary Outcomes (4)

• Rate of Primary Ischemic Endpoint events (CCS)

  Composite of cardiac death, target-vessel myocardial infarction (spontaneous \>48 hours) or definite stent thrombosis.

  3 months

• Rate of Primary Ischemic Endpoint events (NSTE-ACS)

  Composite of cardiac death, target-vessel myocardial infarction (spontaneous \>48 hours) or definite stent thrombosis.

  12 months

• Rate of Primary Bleeding Endpoint event (CCS)

  BARC 3 or 5 bleeding

  3 months

• Rate of Primary Bleeding Endpoint event (NSTE-ACS)

  BARC 3 or 5 bleeding

  12 months

Study Arms (1)

Prasugrel Monotherapy

EXPERIMENTAL

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.

Drug: prasugrel Monotherapy

Interventions

prasugrel Monotherapy DRUG

Prasugrel Monotherapy according to the local dosage (Loading : 20mg, maintenance: 3.75mg/day)

Also known as: PCI with the SYNERGY® stent

Prasugrel Monotherapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Successful PCI with optimal acute stent implantation of one or more SYNERGY stent(s).
• SYNERGY stent implantation was performed to treat:
• at least one de novo lesion with ≥50% diameter stenosis determined by visual assessment in at least one native coronary artery with a vessel size between 2.25 mm and 5.0 mm in diameter.
• Non-acute coronary disease, with normal cardiac biomarker values prior to the PCI procedure, and evidences of myocardial ischemia by symptoms or non-invasive/invasive testing.
• patients with anatomical SYNTAX Score \< 23 prior to PCI
• Patient has provided written informed consent as approved by the Ethical Committee of the respective clinical site.
• Patients with diagnosed Non ST-elevation acute coronary syndrome
• Patients with anatomical SYNTAX Score \< 23 prior to PCI
• Patient provided written informed consent as approved by the Ethical Committee of the respective clinical site
• Post PCI criteria for NSTE-ACS patients
• Patient is free of angina symptoms at the end of PCI procedure.
• Successful PCI with optimal acute stent implantation of one or more SYNERGY stent(s).
• SYNERGY stent implantation was performed to treat at least one de novo lesion with ≥50% diameter stenosis determined by visual assessment in at least one native coronary artery with a vessel size between 2.25 mm and 5.0 mm in diameter.

You may not qualify if:

• Candidates will be ineligible for enrolment in the study if any of the following conditions apply:
• ≤ 20 years of age
• Unable to give Informed Consent
• Females of child-bearing potential unless negative pregnancy test at screening and willing to use effective contraception for the duration of treatment with study medication
• Female who is breastfeeding at time of enrolment
• Patients concomitantly received any other non-study stent at the same procedure
• Patients with planned PCI or surgical intervention to treat any cardiac or non-cardiac condition;
• Previous PCI with any non-SYNERGY stents in the last 6 months
• Current (same hospitalization) or previous (within 12 months) acute coronary syndrome
• Patient with following lesion characteristics prior to PCI; Saphenous or arterial graft, in-stent (re)stenosis
• History of definite stent thrombosis
• Concomitant cardiac valve disease requiring invasive therapy
• Atrial fibrillation or other indication for oral anticoagulant therapy
• Known allergy to aspirin, prasugrel or diagnosed lactose intolerance
• Acute heart failure

Sponsors & Collaborators

• Meditrix Corp: lead
• Fujita Health University: collaborator
• Boston Scientific Japan K.K.: collaborator
• National University of Ireland, Galway, Ireland: collaborator

Study Sites (13)

CORRIB Research Centre for Advanced Imaging and Core laboratoryNational University of Ireland, Galway

Galway, Ireland

Location

Fujita Health University, Okazaki Medical Centre

Okazaki, Aichi-ken, Japan

Location

Fujita Health University

Toyoake, Aichi-ken, 470-1192, Japan

Location

Sapporo Higashi Tokushukai Hospital

Sapporo, Hokkaido, Japan

Location

Iwate Medical University Hopsital

Morioka, Iwate, Japan

Location

St. Marianna University School of Medicine Hospital

Kawasaki, Kanagawa, Japan

Location

JCHO Hoshigaoka Medical center

Hirakata, Osaka, Japan

Location

Kinki University Hospital, Faculty of Medicine

Ōsaka-sayama, Osaka, Japan

Location

Yamaguchi University Hospital

Ube, Yamaguchi, Japan

Location

Mitusi Memorial Hospital

Tokyo, Japan

Location

St. Luke's international hospital

Tokyo, Japan

Location

Teikyo University Hospital

Tokyo, Japan

Location

Toho University Ohashi Medical Center

Tokyo, Japan

Location

Related Publications (7)

• 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.

  PMID: 36936091 BACKGROUND

• 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.

  PMID: 36908118 RESULT

• 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.

  PMID: 38463674 RESULT

• 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.

  PMID: 38272132 RESULT

• 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.

  PMID: 37960875 RESULT

• 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.

  PMID: 39974274 DERIVED

• 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.

  PMID: 39395074 DERIVED

Study Officials

• Patrick W Serruys, MD, PhD

  National University of Ireland, Galway

  STUDY CHAIR

• Yoshinobu Onuma, MD, PhD

  National University of Ireland, Galway

  STUDY CHAIR

• Takashi Muramatsu, MD, PhD

  Fujita Health University

  PRINCIPAL INVESTIGATOR

• Kengo Tanabe, MD, PhD

  Mitsui Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Yukio Ozaki, MD, PhD

  Fujita Health University Hospital and Okazaki Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of interventional Cardiology

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: November 11, 2021
• Study Start: September 15, 2020
• Primary Completion: July 31, 2024
• Study Completion: December 31, 2025
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

IE (1); JP (12)