Acute Coronary Syndrome (ACS) Clinical Trial
— ISAR-REACT 5Official title:
Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome - Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment (ISAR-REACT) 5
Verified date | February 2023 |
Source | Deutsches Herzzentrum Muenchen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 4018 |
Est. completion date | September 2021 |
Est. primary completion date | July 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Universitäts-Herzzentrum Freiburg/ Bad Krozingen | Bad Krozingen | Baden-Württemberg |
Germany | Kerckhoff-Klinik GmbH, Abteilung für Kardiologie | Bad Nauheim | Hessen |
Germany | Segeberger Kliniken GmbH | Bad Segeberg | Schleswig-Holstein |
Germany | Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin | Berlin | |
Germany | Charité Universitätsmedizin Berlin, Campus Virchow-Klinik | Berlin | |
Germany | Klinikum Landkreis Erding | Erding | Bavaria |
Germany | Universitätsmedizin Göttingen, Herzzentrum | Göttingen | Niedersachsen |
Germany | Universitäts-Klinikum Heidelberg | Heidelberg | Baden-Württemberg |
Germany | Universitätsklinikum Schleswig-Holstein, Klinik für Innere Medizin III, Campus Kiel | Kiel | Schleswig-Holstein |
Germany | Universitätsklinikum Mannheim | Mannheim | Baden-Württemberg |
Germany | Deutsches Herzzentrum Munich | München | Bavaria |
Germany | Klinikum Neuperlach | München | Bavaria |
Germany | Klinikum rechts der Isar, 1. Medizinische Klinik und Poliklinik | München | Bavaria |
Germany | Universitätsklinikum Regensburg | Regensburg | Bavaria |
Germany | Klinikum Traunstein | Traunstein | Bavaria |
Germany | Universitätsklinikum Ulm | Ulm | Baden-Württemberg |
Germany | Herzzentrum Wuppertal | Wuppertal | Nordrhein-Westfalen |
Italy | Careggi University Hospital, Invasive Cardiology Division | Firenze | |
Italy | Spaziani Hospital Frosinone | Frosinone |
Lead Sponsor | Collaborator |
---|---|
Deutsches Herzzentrum Muenchen | Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK) |
Germany, Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite of death, myocardial infarction or stroke | 12 months | ||
Secondary | Bleeding | Bleeding according to BARC | 12 months | |
Secondary | Mortality | Death for any cause | 12 months | |
Secondary | Stroke | Stroke | 12 months | |
Secondary | Myocardial Infarction | 12 months | ||
Secondary | Stent Thrombosis | Stent thrombosis according to ARC | 12 months |
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