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Chronic Coronary SyndromeASET-JAPANNCT05117866

Acetyl Salicylic Elimination Trial JAPAN: The ASET JAPAN Pilot Study

A study testing prasugrel Monotherapy in people with Chronic Coronary Syndrome and Non ST Segment Elevation Acute Coronary Syndrome, run by Meditrix Corp at 13 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
prasugrel Monotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
307 participants
Where
13 sitesin 2 countries
Study dates
15 Sep 2020to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 13Show fewer
  • 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.

Who cannot join

  • 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
Show all 59Show fewer
  • 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
  • Active myocarditis
  • Cardiomyopathy
  • Patient in hemodialysis
  • Treatment in the last 10 days or requirement for ongoing treatment with a strong CYP3A4 inhibitor or inducer;
  • History of stroke or transient ischemic cerebrovascular accident
  • History of intracranial hemorrhage or other intracranial pathology associated with increased bleeding risk
  • Hemoglobin <10 g/dL or other evidence of active bleeding
  • Peptic ulceration documented by endoscopy within the last 3 months unless healing proven by repeat endoscopy
  • Any other condition deemed by the investigator to place the patient at excessive risk of bleeding with prasugrel
  • Participation in another trial with an investigational drug or device
  • Co-morbidity associated with life expectancy <1 year
  • Assessment that the subject is not likely to comply with the study procedures or have complete follow-up
  • Known drug or alcohol dependence within the past 12 months as judged by the investigator
  • Candidates will be ineligible for enrolment 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
  • 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
  • Known allergy to aspirin, prasugrel or diagnosed lactose intolerance
  • Atrial fibrillation or other indication for oral anticoagulant therapy;
  • History of stroke or transient ischemic cerebrovascular accident
  • History of intracranial haemorrhage or other intracranial pathology associated with increased bleeding risk
  • Acute heart failure
  • Active myocarditis
  • Cardiomyopathy
  • Patient in hemodialysis
  • Haemoglobin <10 g/dL or other evidence of active bleeding
  • Hemodynamic instability or cardiogenic shock
  • Recurrent or ongoing chest pain refractory to medical treatment
  • Life-threatening arrhythmias or cardiac arrest;
  • Mechanical complications of myocardial infarction
  • Recurrent dynamic ST-T wave changes, particularly with intermittent ST-elevation
  • Peptic ulceration documented by endoscopy within the last 3 months unless healing proven by repeat endoscopy
  • Any other condition deemed by the investigator to place the patient at excessive risk of bleeding with prasugrel
  • Participation in another trial with an investigational drug or device
  • Co-morbidity associated with life expectancy < 1 year
  • Assessment that the subject is not likely to comply with the study procedures or have complete follow-up;
  • Known drug or alcohol dependence within the past 12 months as judged by the investigator

Trial locations and contacts

13 sites in 2 countries.

13 sites in 2 countries

Japan12 sites

  • JCHO Hoshigaoka Medical center

    Hirakata, Osaka

  • St. Marianna University School of Medicine Hospital

    Kawasaki, Kanagawa

  • Iwate Medical University Hopsital

    Morioka, Iwate

  • Fujita Health University, Okazaki Medical Centre

    Okazaki, Aichi-ken

  • Kinki University Hospital, Faculty of Medicine

    Ōsaka-sayama, Osaka

  • Sapporo Higashi Tokushukai Hospital

    Sapporo, Hokkaido

  • Mitusi Memorial Hospital

    Tokyo

  • St. Luke's international hospital

    Tokyo

  • Teikyo University Hospital

    Tokyo

  • Toho University Ohashi Medical Center

    Tokyo

  • Fujita Health University

    Toyoake, Aichi-ken, 470-1192

  • Yamaguchi University Hospital

    Ube, Yamaguchi

Other trials in Japan

Ireland1 site

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

    Galway

Other trials in Ireland

About this study

Official title: A Multicenter, Single Arm, Open-label Trial of Prasugrel Monotherapy After PCI With the SYNERGY® Stent in Patients With Chronic Coronary Syndrome or Non-ST-elevation Acute Coronary Syndromes

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.

  1. 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).
Read more

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).

Being tested
prasugrel Monotherapy
Keywords
prasugrel monotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • prasugrel MonotherapyDrug

    Also called PCI with the SYNERGY® stent

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

Study groups in NCT05117866
Study groupRoleWhat they receive
Prasugrel MonotherapyExperimentalThe 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.
Receives: Drug: prasugrel Monotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Primary Ischemic Endpoint events (CCS)

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

    Measured: 3 months

  2. Rate of Primary Ischemic Endpoint events (NSTE-ACS)

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

    Measured: 12 months

  3. Rate of Primary Bleeding Endpoint event (CCS)

    BARC 3 or 5 bleeding

    Measured: 3 months

  4. Rate of Primary Bleeding Endpoint event (NSTE-ACS)

    BARC 3 or 5 bleeding

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2021
  2. Study start15 Sep 2020
  3. Primary completion31 Jul 2024
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
307 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05117866
Sponsor's protocol ID
CR20-023
Acronym
ASET-JAPAN
Status last verified
Aug 2024
First submitted
16 Sep 2021
Last updated
22 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 36936091

  • 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.

    PubMed 36908118

  • 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.

    PubMed 38463674

  • 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.

    PubMed 38272132

  • 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.

    PubMed 37960875

  • 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.

    PubMed 42142096

  • 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.

    PubMed 39974274

  • 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.

    PubMed 39395074

Questions about this trial

What is this clinical trial studying?

A study testing prasugrel Monotherapy in people with Chronic Coronary Syndrome and Non ST Segment Elevation Acute Coronary Syndrome, run by Meditrix Corp at 13 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 59 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Japan, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Primary Ischemic Endpoint events (CCS) (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05117866, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.

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