Acetyl Salicylic Elimination Trial JAPAN: The ASET JAPAN Pilot Study

Inclusion Criteria:

Inclusion Criteria for CCS patients (phase 1) :

1. Successful PCI with optimal acute stent implantation of one or more SYNERGYstent(s).

2. SYNERGY stent implantation was performed to treat:

3. at least one de novo lesion with ≥50% diameter stenosis determined by visualassessment in at least one native coronary artery with a vessel size between 2.25 mm and 5.0 mm in diameter.

4. Non-acute coronary disease, with normal cardiac biomarker values prior to thePCI procedure, and evidences of myocardial ischemia by symptoms ornon-invasive/invasive testing.

5. patients with anatomical SYNTAX Score < 23 prior to PCI

6. Patient has provided written informed consent as approved by the Ethical Committeeof the respective clinical site.

Inclusion Criteria for NSTE-ACS patients (phase 2) :

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 ofthe 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 SYNERGYstent(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 nativecoronary 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:

1. ≤ 20 years of age

2. Unable to give Informed Consent

3. Females of child-bearing potential unless negative pregnancy test at screening andwilling to use effective contraception for the duration of treatment with studymedication

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 ornon-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 coronarysyndrome

9. Patient with following lesion characteristics prior to PCI; Saphenous or arterialgraft, 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 strongCYP3A4 inhibitor or inducer;

19. History of stroke or transient ischemic cerebrovascular accident

20. History of intracranial hemorrhage or other intracranial pathology associated withincreased 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 healingproven by repeat endoscopy

23. Any other condition deemed by the investigator to place the patient at excessiverisk 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 orhave complete follow-up

27. Known drug or alcohol dependence within the past 12 months as judged by theinvestigator

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

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 andwilling to use effective contraception for the duration of treatment with studymedication

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 ornon-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 arterialgraft, 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 withincreased 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 healingproven by repeat endoscopy

26. Any other condition deemed by the investigator to place the patient at excessiverisk 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 orhave complete follow-up;

30. Known drug or alcohol dependence within the past 12 months as judged by theinvestigator