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

Exclusion Criteria

• •1. intolerance of or allergy to ticagrelor or prasugrel
• •2. history of any stroke, transient ischemic attack or intracranial bleeding
• •3. known 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. known platelet count \< 100.000/μL at the time of screening
• •7. known 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 (e.g. ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, grapefruit juice \> 1 L/d), CYP3A substrates with narrow therapeutic indices (e.g. cyclosporine, quinidine), or strong CYP3A inducers (e.g. rifampin/rifampicin, phenytoin, carbamazepine, dexamethason, phenobarbital ) that cannot be safely discontinued
• •16. ≥1 doses of ticagrelor or prasugrel within 5 days before randomisation
• •17. no written informed consent
• •18. participation in another investigational drug study
• •19. previous enrolment in this study
• •20. for women of childbearing potential no negative pregnancy test and no agree to use reliable method of birth control during the study
• •21. Pregnancy, giving birth within the last 90 days, or lactation
• •22. inability to cooperate with protocol requirements