Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome

Major Inclusion Criteria:

Hospitalization for an acute coronary syndrome (ST-segment elevation myocardial
infarction, non-ST-segment elevation myocardial infarction or unstable angina pectoris)
with planned invasive strategy

Major Exclusion Criteria:

1. intolerance of or allergy to ticagrelor or prasugrel

2. history of any stroke or transient ischemic attack

3. intracranial neoplasm, intracranial arteriovenous malformation or intracranial
aneurysm

4. active bleeding, clinical findings, that in the judgement of the investigator are
associated with an increased risk of bleeding

5. fibrin-specific fibrinolytic therapy less than 24 h before randomization,
non-fibrin-specific fibrinolytic therapy less than 48 h before randomization

6. platelet count < 100.000/μL at the time of screening

7. anemia (hemoglobin <10 g/dL) at the time of screening

8. oral anticoagulation that cannot be safely discontinued for the duration of the study

9. INR known to be greater than 1.5 at the time of screening

10. chronic renal insufficiency requiring dialysis

11. moderate or severe hepatic dysfunction (Child Pugh B or C)

12. increased risk of bradycardia events (Sick Sinus, AV block grade II or III,
bradycardia-induced syncope)

13. index event is an acute complication (< 30 days) of PCI

14. concomitant medical illness that in the opinion of the investigator is associated
with a life expectancy < 1 year

15. concomitant oral or i.v. therapy with strong CYP3A Inhibitors, CYP3A substrates with
narrow therapeutic indices or strong CYP3A inducers that cannot be safely
discontinued

16. ≥1 doses of ticagrelor or prasugrel within 5 days before randomisation

17. participation in another investigational drug study

18. previous enrolment in this study

19. pregnancy, giving birth within the last 90 days, or lactation

20. inability to cooperate with protocol requirements