Clinical trial NCT01944800: Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Coronary Syndrome (ACS)
Keywords: Ticagrelor
Prasugrel
Acute coronary syndrome
Percutaneous coronary intervention
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
Collaborators: name: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
First posted: 2013-09-18
Enrollment: 4018
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Composite of death, myocardial infarction or stroke
timeFrame: 12 months
Secondary outcomes:
measure: Bleeding
timeFrame: 12 months
measure: Mortality
timeFrame: 12 months
measure: Stroke
timeFrame: 12 months
measure: Myocardial Infarction
timeFrame: 12 months
measure: Stent Thrombosis
timeFrame: 12 months
Other outcomes:
Locations:
city: Bad Krozingen
country: Germany
facility: Universitäts-Herzzentrum Freiburg/ Bad Krozingen
state: Baden-Württemberg
city: Heidelberg
country: Germany
facility: Universitäts-Klinikum Heidelberg
state: Baden-Württemberg
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim
state: Baden-Württemberg
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
state: Baden-Württemberg
city: Erding
country: Germany
facility: Klinikum Landkreis Erding
state: Bavaria
city: München
country: Germany
facility: Deutsches Herzzentrum Munich
state: Bavaria
city: München
country: Germany
facility: Klinikum rechts der Isar, 1. Medizinische Klinik und Poliklinik
state: Bavaria
city: München
country: Germany
facility: Klinikum Neuperlach
state: Bavaria
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
state: Bavaria
city: Traunstein
country: Germany
facility: Klinikum Traunstein
state: Bavaria
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik GmbH, Abteilung für Kardiologie
state: Hessen
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen, Herzzentrum
state: Niedersachsen
city: Wuppertal
country: Germany
facility: Herzzentrum Wuppertal
state: Nordrhein-Westfalen
city: Bad Segeberg
country: Germany
facility: Segeberger Kliniken GmbH
state: Schleswig-Holstein
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Klinik für Innere Medizin III, Campus Kiel
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin, Campus Virchow-Klinik
city: Firenze
country: Italy
facility: Careggi University Hospital, Invasive Cardiology Division
city: Frosinone
country: Italy
facility: Spaziani Hospital Frosinone
Study officials:
affiliation: Deutsches Herzzentrum München
name: Adnan Kastrati, MD
role: STUDY_CHAIR
affiliation: Deutsches Herzzentrum München
name: Stefanie Schuepke, MD
role: PRINCIPAL_INVESTIGATOR
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