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Acetyl Salicylic Elimination Trial JAPAN: The ASET JAPAN Pilot Study (ASET-JAPAN)

Primary Purpose

Chronic Coronary Syndrome, Non ST Segment Elevation Acute Coronary Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
prasugrel Monotherapy
Sponsored by
Meditrix Corp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Coronary Syndrome focused on measuring prasugrel monotherapy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Inclusion Criteria phase 1 for CCS patients :

  1. Successful PCI with optimal acute stent implantation results (based on local standard of care by angiography and/or findings from intracoronary imaging and on investigators' discretion) of one or more everolimus-eluting SYNERGY® stent(s). Typically, optimal acute coronary stenting result is a combination of successful stent implantation at the target lesion with absence of significant residual diameter stenosis (<20%), no edge dissection, no thrombus, no major side branch occlusion, "no-reflow", no major stent underexpansion or major stent incomplete apposition.
  2. Everolimus-eluting SYNERGY® stent implantation was performed to treat:

    1. patients with at least one stenosis (angiographic, visually determined de novo lesions with ≥50% Diameter Stenosis [DS]) in at least one major epicardial territory (Left Anterior Descending artery [LAD] and/or side branch, Circumflex artery [CX] and/or side branch, Right Coronary Artery [RCA] and/or side branch) with a vessel size between 2.25 mm and 5.0 mm in diameter supplying viable myocardium without left main stem involvement;
    2. 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 (e.g. treadmill exercise test, radionuclide scintigraphy, stress echocardiography, fractional flow reserve);
    3. patients anatomical SYNTAX Score < 23 prior to everolimus-eluting SYNERGY® stent implantation;
  3. Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee of the respective clinical site;

Inclusion Criteria phase 2 NSTE-ACS patients :

  1. Patients with diagnosed Non ST-elevation acute coronary syndrome;
  2. Patients anatomical SYNTAX Score < 23 prior to everolimus-eluting SYNERGY® stent implantation;
  3. Patient has been informed of the nature of the study and agrees to its requirements and has provided written informed consent as approved by the Ethical Committee of the respective clinical site;

    Inclusion criteria post-PCI for NSTE-ACS patients:

  4. Patient is free of angina symptoms at the end of PCI procedure.
  5. Successful primary PCI with optimal acute stent implantation results (based on local standard of care by angiography and/or findings from intracoronary imaging and on investigators' discretion) of one or more everolimus-eluting SYNERGY® stent(s). Typically, optimal acute coronary stenting result is a combination of successful stent implantation at the target lesion with absence of significant residual diameter stenosis (<20%), edge dissection, thrombus, major side branch occlusion, "no-reflow" at the end of the procedure, major stent under expansion or major stent incomplete apposition and absence of persistent chest pain after the procedure.
  6. Everolimus-eluting SYNERGY® stent implantation was performed to treat:

    1. patients with at least one stenosis (angiographic, visually determined de novo lesions with ≥50% DS) in at least one major epicardial territory (LAD and/or side branch, CX and/or side branch, RCA and/or side branch) with a vessel size between 2.25 mm and 5.0 mm in diameter supplying viable myocardium without left main stem involvement;

Exclusion Criteria:

Exclusion Criteria for CCS patients (phase 1):

Candidates will be ineligible for enrolment in the study if any of the following conditions apply:

  1. Under the age of 20 years;
  2. Unable to give Informed Consent;
  3. Females of child-bearing potential unless negative pregnancy test at screening and willing to use effective contraception (i.e. established use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or barrier methods of contraception with spermicide or sole male partner with prior vasectomy and confirmed absence of sperm in ejaculate) for the duration of treatment with study medication.
  4. Female who is breastfeeding at time of enrolment;
  5. Patients treated with everolimus-eluting SYNERGY® stent(s) but who also concomitantly received any other non-study stent at the same procedure (all lesions must be treated with the everolimus-eluting SYNERGY® stent);
  6. Patients with planned PCI or surgical intervention to treat any cardiac or non-cardiac condition;
  7. Previous PCI with any non-SYNERGY® stents in the last 12 months;
  8. Current (same hospitalization) or previous (within 12 months) acute coronary syndrome
  9. Patient with following lesion characteristics prior to everolimus-eluting SYNERGY® stent implantation:

    • Left-main disease
    • Chronic Total Occlusion
    • Bifurcation lesion requiring two stent treatment
    • Saphenous or arterial graft
    • Severe calcification necessitating the use of rotablator
    • in-stent (re)stenosis
    • thrombosis of the target lesion;
  10. Patients with any previous history of definite stent thrombosis.
  11. Concomitant cardiac valve disease requiring invasive therapy (reconstruction or replacement);
  12. Atrial fibrillation or other indication for oral anticoagulant therapy;
  13. Known allergy to aspirin, prasugrel or diagnosed lactose intolerance;
  14. Acute heart failure;
  15. Active myocarditis;
  16. Cardiomyopathy;
  17. Patients treated with hemodialysis;
  18. Treatment in the last 10 days or requirement for ongoing treatment with a strong CYP3A4 inhibitor or inducer;
  19. Previous stroke or transient ischemic cerebrovascular accident (TIA);
  20. Previous history of intracranial haemorrhage or other intracranial pathology associated with increased bleeding risk;
  21. Haemoglobin <10 g/dL or other evidence of active bleeding;
  22. Peptic ulceration documented by endoscopy within the last 3 months unless healing proven by repeat endoscopy;
  23. Any other condition deemed by the investigator to place the patient at excessive risk of bleeding with prasugrel;
  24. Participation in another trial with an investigational drug or device;
  25. Co-morbidity associated with life expectancy less than 1 year;
  26. Assessment that the subject is not likely to comply with the study procedures or have complete follow-up;
  27. Known drug or alcohol dependence within the past 12 months as judged by the investigator.

Exclusion Criteria for NSTE-ACS patients (Phase 2):

  1. Under the age of 20 years;
  2. Unable to give Informed Consent;
  3. Females of child-bearing potential unless negative pregnancy test at screening and willing to use effective contraception (i.e. established use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or barrier methods of contraception with spermicide or sole male partner with prior vasectomy and confirmed absence of sperm in ejaculate) for the duration of treatment with study medication;
  4. Female who is breastfeeding at time of enrolment;
  5. Patients treated with everolimus-eluting SYNERGY® stent(s) but who also concomitantly received any other non-study stent at the same procedure (all lesions must be treated with everolimus-eluting SYNERGY® stent);
  6. Patients with planned staged PCI or surgical intervention to treat any cardiac or non-cardiac condition;
  7. Previous PCI with any non-SYNERGY® stents in the last 12 months;
  8. Patient with following (target) lesion characteristics:

    • Left-main disease
    • Chronic Total Occlusion
    • Bifurcation lesion requiring two stent treatment
    • Saphenous or arterial graft
    • Severe calcification necessitating the use of rotablator
    • in-stent (re)stenosis
    • thrombosis of the target lesion;
  9. Patients with any previous history of definite stent thrombosis;
  10. Concomitant cardiac valve disease requiring invasive therapy (reconstruction or replacement);
  11. Known allergy to aspirin, prasugrel (or ticagrelor) or diagnosed lactose intolerance;
  12. Previous stroke or transient ischemic cerebrovascular accident (TIA);
  13. Previous history of intracranial haemorrhage or other intracranial pathology associated with increased bleeding risk;
  14. Peptic ulceration documented by endoscopy within the last 3 months unless healing proven by repeat endoscopy;
  15. Hemodynamic instability or cardiogenic shock;
  16. Recurrent or ongoing chest pain refractory to medical treatment;
  17. Life-threatening arrhythmias or cardiac arrest;
  18. Mechanical complications of Myocardial Infarction;
  19. Acute heart failure;
  20. Recurrent dynamic ST-T wave changes, particularly with intermittent ST-elevation;
  21. Atrial fibrillation or other indication for oral anticoagulant therapy;
  22. Myocarditis;
  23. Cardiomyopathy;
  24. Patients treated with hemodialysis;
  25. Haemoglobin <10 g/dL or other evidence of active bleeding;
  26. Any other condition deemed by the investigator to place the patient at excessive risk of bleeding with prasugrel;
  27. Participation in another trial with an investigational drug or device;
  28. Assessment that the subject is not likely to comply with the study procedures or have complete follow-up;
  29. Known drug or alcohol dependence within the past 12 months as judged by the investigator;
  30. Co-morbidity associated with life expectancy less than 1 year.

Sites / Locations

  • CORRIB Research Centre for Advanced Imaging and Core laboratoryNational University of Ireland, Galway
  • Fujita Health University, Okazaki Medical CentreRecruiting
  • Fujita Health UniversityRecruiting
  • Sapporo Higashi Tokushukai HospitalRecruiting
  • Iwate Medical University HopsitalRecruiting
  • St. Marianna University School of Medicine HospitalRecruiting
  • JCHO Hoshigaoka Medical centerRecruiting
  • Kinki University Hospital, Faculty of MedicineRecruiting
  • Yamaguchi University HospitalRecruiting
  • Mitusi Memorial HospitalRecruiting
  • St. Luke's international hospitalRecruiting
  • Teikyo University HospitalRecruiting
  • Toho University Ohashi Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prasugrel Monotherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Rate of Primary Ischemic Endpoint events (CCS)
Composite of cardiac death, target-vessel myocardial infarction (spontaneous >48 hours) or definite stent thrombosis.
Rate of Primary Ischemic Endpoint events (NSTE-ACS)
Composite of cardiac death, target-vessel myocardial infarction (spontaneous >48 hours) or definite stent thrombosis.
Rate of Primary Bleeding Endpoint event (CCS)
BARC 3 or 5 bleeding
Rate of Primary Bleeding Endpoint event (NSTE-ACS)
BARC 3 or 5 bleeding

Secondary Outcome Measures

Full Information

First Posted
September 16, 2021
Last Updated
May 1, 2023
Sponsor
Meditrix Corp
Collaborators
Fujita Health University, Boston Scientific Japan K.K., National University of Ireland, Galway, Ireland
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1. Study Identification

Unique Protocol Identification Number
NCT05117866
Brief Title
Acetyl Salicylic Elimination Trial JAPAN: The ASET JAPAN Pilot Study
Acronym
ASET-JAPAN
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meditrix Corp
Collaborators
Fujita Health University, Boston Scientific Japan K.K., National University of Ireland, Galway, Ireland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Coronary Syndrome, Non ST Segment Elevation Acute Coronary Syndrome
Keywords
prasugrel monotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prasugrel Monotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
prasugrel Monotherapy
Other Intervention Name(s)
PCI with the SYNERGY® stent
Intervention Description
Prasugrel Monotherapy according to the local dosage (Loading : 20mg, maintenance: 3.75mg/day)
Primary Outcome Measure Information:
Title
Rate of Primary Ischemic Endpoint events (CCS)
Description
Composite of cardiac death, target-vessel myocardial infarction (spontaneous >48 hours) or definite stent thrombosis.
Time Frame
3 months
Title
Rate of Primary Ischemic Endpoint events (NSTE-ACS)
Description
Composite of cardiac death, target-vessel myocardial infarction (spontaneous >48 hours) or definite stent thrombosis.
Time Frame
12 months
Title
Rate of Primary Bleeding Endpoint event (CCS)
Description
BARC 3 or 5 bleeding
Time Frame
3 months
Title
Rate of Primary Bleeding Endpoint event (NSTE-ACS)
Description
BARC 3 or 5 bleeding
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion Criteria for CCS patients (phase 1) : 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. Inclusion Criteria for NSTE-ACS patients (phase 2) : 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. Exclusion Criteria: Exclusion Criteria for CCS patients (phase 1): 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 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 Exclusion Criteria for NSTE-ACS patients (Phase 2): 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emelyne Sevestre, BA
Phone
+353871646680
Ext
+353
Email
emelyne.sevestre@nuigalway.ie
First Name & Middle Initial & Last Name or Official Title & Degree
Shinichiro Masuda, MD
Phone
+353830139594
Email
S.masuda1@nuigalway.ie
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick W Serruys, MD, PhD
Organizational Affiliation
National University of Ireland, Galway
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yoshinobu Onuma, MD, PhD
Organizational Affiliation
National University of Ireland, Galway
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Takashi Muramatsu, MD, PhD
Organizational Affiliation
Fujita Health University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kengo Tanabe, MD, PhD
Organizational Affiliation
Mitsui Memorial Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yukio Ozaki, MD, PhD
Organizational Affiliation
Fujita Health University Hospital and Okazaki Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
CORRIB Research Centre for Advanced Imaging and Core laboratoryNational University of Ireland, Galway
City
Galway
Country
Ireland
Individual Site Status
Active, not recruiting
Facility Name
Fujita Health University, Okazaki Medical Centre
City
Okazaki
State/Province
Aichi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yukio Ozaki, MD, PhD
Facility Name
Fujita Health University
City
Toyoake
State/Province
Aichi
ZIP/Postal Code
470-1192
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takashi Muramatsu, MD;PhD
Phone
+81-(0)562-93-2884
Email
takam0401@gmail.com
Facility Name
Sapporo Higashi Tokushukai Hospital
City
Sapporo
State/Province
Hokkaido
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuki Katagiri, MD, PhD
Facility Name
Iwate Medical University Hopsital
City
Morioka
State/Province
Iwate
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoshihiro Morino, MD
Facility Name
St. Marianna University School of Medicine Hospital
City
Kawasaki
State/Province
Kanagawa
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuki Ishibashi, MD, PhD
Facility Name
JCHO Hoshigaoka Medical center
City
Hirakata
State/Province
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shimpei Nakatani, MD, PhD
Facility Name
Kinki University Hospital, Faculty of Medicine
City
Ōsaka-sayama
State/Province
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaku Nakazawa, MD
First Name & Middle Initial & Last Name & Degree
Kuniaki Takahashi, MD
Facility Name
Yamaguchi University Hospital
City
Ube
State/Province
Yamaguchi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takayuki Okamura, MD, PhD
First Name & Middle Initial & Last Name & Degree
Yosuke Miyazaki, MD, PhD
First Name & Middle Initial & Last Name & Degree
Hiroki Tateishi, MD, PhD
Facility Name
Mitusi Memorial Hospital
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kengo Tanabe, MD, PhD
Facility Name
St. Luke's international hospital
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taku Asano, MD, PhD
Facility Name
Teikyo University Hospital
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ken Kozuma, MD, PhD
First Name & Middle Initial & Last Name & Degree
Hideyuki Kawashima, MD
Facility Name
Toho University Ohashi Medical Center
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masato Nakamura, MD, PhD
First Name & Middle Initial & Last Name & Degree
Norihiro Kogame

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Acetyl Salicylic Elimination Trial JAPAN: The ASET JAPAN Pilot Study

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