Acetyl Salicylic Elimination Trial JAPAN: The ASET JAPAN Pilot Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

307 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-15

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety of Aspirin and Clopidogrel in the Atrial Fibrillation With Low or Moderate Stroke Risk

NCT02960126

Atrial Fibrillation

UNKNOWN PHASE3

Efficacy and Safety of Aspirin in Patients With Chronic Coronary Syndromes Without Revascularization

NCT05347069

Stable Angina Pectoris Coronary Artery Disease Ischemic Heart Disease

RECRUITING PHASE4

ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-3 Study

NCT04609111

Acute Coronary Syndrome

ACTIVE_NOT_RECRUITING PHASE4

Aspirin and a PoTent P2Y12 Inhibitor Versus Aspirin and Clopidogrel in Patients Undergoing PCI for Complex Lesion

NCT04014803

Coronary Artery Disease

RECRUITING PHASE4

Comparison of the VerifyNow® Aspirin Test and PRUTest® Platelet Reactivity Tests With Investigational Reagent to Reagents Registered in Japan

NCT03615846

Platelet Aggregation Coronary Artery Disease

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Coronary Syndrome Non ST Segment Elevation Acute Coronary Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Prasugrel Monotherapy

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.

Group Type EXPERIMENTAL

prasugrel Monotherapy

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

prasugrel Monotherapy

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PCI with the SYNERGY® stent

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Successful PCI with optimal acute stent implantation of one or more SYNERGY stent(s).
2. SYNERGY stent implantation was performed to treat:

1. 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.
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.
3. patients with anatomical SYNTAX Score \< 23 prior to PCI
3. Patient has provided written informed consent as approved by the Ethical Committee of the respective clinical site.

1. Patients with diagnosed Non ST-elevation acute coronary syndrome
2. Patients with anatomical SYNTAX Score \< 23 prior to PCI
3. Patient provided written informed consent as approved by the Ethical Committee of the respective clinical site

Post PCI criteria for NSTE-ACS patients

1. Patient is free of angina symptoms at the end of PCI procedure.
2. Successful PCI with optimal acute stent implantation of one or more SYNERGY stent(s).
3. 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

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

1. ≤ 20 years of age
2. Unable to give Informed Consent
3. 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
4. Female who is breastfeeding at time of enrolment
5. Patients concomitantly received any other non-study stent at the same procedure
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 6 months
8. Current (same hospitalization) or previous (within 12 months) acute coronary syndrome
9. Patient with following lesion characteristics prior to PCI; Saphenous or arterial graft, in-stent (re)stenosis
10. History of definite stent thrombosis
11. Concomitant cardiac valve disease requiring invasive therapy
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. Patient in hemodialysis
18. Treatment in the last 10 days or requirement for ongoing treatment with a strong CYP3A4 inhibitor or inducer;
19. History of stroke or transient ischemic cerebrovascular accident
20. History of intracranial hemorrhage or other intracranial pathology associated with increased bleeding risk
21. Hemoglobin \<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 \<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

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

1. ≤ 20 years of age
2. Unable to give Informed Consent
3. 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
4. Female who is breastfeeding at time of enrolment
5. Patients concomitantly received any other non-study stent at the same procedure
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 6 months
8. Patient with following lesion characteristics prior to PCI; Saphenous or arterial graft, in-stent (re)stenosis
9. History of definite stent thrombosis
10. Concomitant cardiac valve disease requiring invasive therapy
11. Known allergy to aspirin, prasugrel or diagnosed lactose intolerance
12. Atrial fibrillation or other indication for oral anticoagulant therapy;
13. History of stroke or transient ischemic cerebrovascular accident
14. History of intracranial haemorrhage or other intracranial pathology associated with increased bleeding risk
15. Acute heart failure
16. Active myocarditis
17. Cardiomyopathy
18. Patient in hemodialysis
19. Haemoglobin \<10 g/dL or other evidence of active bleeding
20. Hemodynamic instability or cardiogenic shock
21. Recurrent or ongoing chest pain refractory to medical treatment
22. Life-threatening arrhythmias or cardiac arrest;
23. Mechanical complications of myocardial infarction
24. Recurrent dynamic ST-T wave changes, particularly with intermittent ST-elevation
25. Peptic ulceration documented by endoscopy within the last 3 months unless healing proven by repeat endoscopy
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. Co-morbidity associated with life expectancy \< 1 year
29. Assessment that the subject is not likely to comply with the study procedures or have complete follow-up;
30. Known drug or alcohol dependence within the past 12 months as judged by the investigator

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No