Acetyl Salicylic Elimination Trial JAPAN: The ASET JAPAN Pilot Study

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