Acute Coronary Syndrome (ACS)
Conditions
Keywords
Ticagrelor, Prasugrel, Acute coronary syndrome, Percutaneous coronary intervention
Brief summary
Aim of the randomized, open-label, multicenter ISAR-REACT 5 trial is to assess whether ticagrelor is superior to prasugrel in patients with acute coronary syndrome and planned invasive strategy in terms of clinical outcomes.
Interventions
DRUGTicagrelor
Loading dose of 180 mg, followed by maintenance dose of 180 mg per day
DRUGPrasugrel
Loading dose of 60 mg, followed by maintenance dose of 10 mg/day or 5 mg/day in patients =/\> 75 years or \< 60 kg
Sponsors
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Deutsches Herzzentrum Muenchen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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, 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of death, myocardial infarction or stroke | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding | 12 months | Bleeding according to BARC |
| Mortality | 12 months | Death for any cause |
| Stroke | 12 months | Stroke |
| Myocardial Infarction | 12 months | — |
| Stent Thrombosis | 12 months | Stent thrombosis according to ARC |
Countries
Germany, Italy
Outcome results
None listed