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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01944800
Other study ID # GE IDE 00113
Secondary ID 2013-002272-40
Status Completed
Phase Phase 4
First received
Last updated
Start date September 15, 2013
Est. completion date September 2021

Study information

Verified date February 2023
Source Deutsches Herzzentrum Muenchen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
Ticagrelor
Loading dose of 180 mg, followed by maintenance dose of 180 mg per day
Prasugrel
Loading dose of 60 mg, followed by maintenance dose of 10 mg/day or 5 mg/day in patients =/> 75 years or < 60 kg

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Deutsches Herzzentrum Muenchen Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Countries where clinical trial is conducted

Germany,  Italy, 

Outcome

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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