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:

• intolerance of or allergy to ticagrelor or prasugrel
• history of any stroke, transient ischemic attack or intracranial bleeding
• known intracranial neoplasm, intracranial arteriovenous malformation or intracranial aneurysm
• active bleeding, clinical findings, that in the judgement of the investigator are associated with an increased risk of bleeding
• fibrin-specific fibrinolytic therapy less than 24 h before randomization, non-fibrin-specific fibrinolytic therapy less than 48 h before randomization
• known platelet count < 100.000/μL at the time of screening
• known anemia (hemoglobin <10 g/dL) at the time of screening
• oral anticoagulation that cannot be safely discontinued for the duration of the study
• INR known to be greater than 1.5 at the time of screening
• chronic renal insufficiency requiring dialysis
• moderate or severe hepatic dysfunction (Child Pugh B or C)
• increased risk of bradycardia events (Sick Sinus, AV block grade II or III, bradycardia-induced syncope)
• index event is an acute complication (< 30 days) of PCI
• concomitant medical illness that in the opinion of the investigator is associated with a life expectancy < 1 year
• 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
• ≥1 doses of ticagrelor or prasugrel within 5 days before randomisation
• no written informed consent
• participation in another investigational drug study
• previous enrolment in this study
• for women of childbearing potential no negative pregnancy test and no agree to use reliable method of birth control during the study
• Pregnancy, giving birth within the last 90 days, or lactation
• inability to cooperate with protocol requirements