Acetyl Salicylic Elimination Trial JAPAN: The ASET JAPAN Pilot Study

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