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Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome (ISAR-REACT 5)

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ClinicalTrials.gov Identifier: NCT01944800
Recruitment Status : Recruiting
First Posted : September 18, 2013
Last Update Posted : March 13, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome (ACS) Drug: Ticagrelor Drug: Prasugrel Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2013
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Ticagrelor Drug: Ticagrelor
Loading dose of 180 mg, followed by maintenance dose of 180 mg per day
Other Name: Brilique
Active Comparator: Prasugrel Drug: 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
Other Name: Efient


Outcome Measures

Primary Outcome Measures :
  1. Composite of death, myocardial infarction or stroke [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Bleeding [ Time Frame: 12 months ]
    Bleeding according to BARC

  2. Mortality [ Time Frame: 12 months ]
    Death for any cause

  3. Stroke [ Time Frame: 12 months ]
    Stroke

  4. Myocardial Infarction [ Time Frame: 12 months ]
  5. Stent Thrombosis [ Time Frame: 12 months ]
    Stent thrombosis according to ARC


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01944800


Contacts
Contact: Stefanie Schuepke, MD +49-89-1218- ext 0 schuepke@dhm.mhn.de
Contact: Deborah-Ann Schuster +49-89-1218 ext 1528 schuster@dhm.mhn.de

Locations
Germany
Universitäts-Herzzentrum Freiburg/ Bad Krozingen Recruiting
Bad Krozingen, Baden-Württemberg, Germany, 79189
Contact: Franz-Josef Neumann, MD    +49 7633 402-2000    franz-josef.neumann@universitaets-herzzentrum.de   
Contact: Barbara Steiger    +49 7633 402-5204    Barbara.Steiger@universitaets-herzzentrum.de   
Principal Investigator: Franz-Josef Neumann, MD         
Sub-Investigator: Dietmar Trenk, MD         
Universitäts-Klinikum Heidelberg Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Contact: Hugo A. Katus, MD    +49 6221 - 56 8670    hugo.katus@med.uni-heidelberg.de   
Contact: Heidi Deigentasch, SC       Heidi.Deigentasch@med.uni-heidelberg.de   
Principal Investigator: Hugo A. Katus, MD         
Sub-Investigator: Evangelos Giannitsis, MD         
Universitätsklinikum Mannheim Recruiting
Mannheim, Baden-Württemberg, Germany, 68167
Contact: Ibrahim Akin, MD    +49 621 383-2204    Ibrahim.Akin@umm.de   
Contact: Stefanie Dorn, SC       Stefanie.Dorn@umm.de   
Principal Investigator: Ibrahim Akin, MD         
Sub-Investigator: Michael Behnes, MD         
Universitätsklinikum Ulm Recruiting
Ulm, Baden-Württemberg, Germany, 89081
Contact: Jochen Wöhrle, MD    +49 731 500 450 28 (-01)    jochen.woehrle@uniklinik-ulm.de   
Contact: Alexandra Maaß, SC    +49 (0)731-500-45006    Alexandra.Maass@uniklinik-ulm.de   
Principal Investigator: Jochen Wöhrle, MD         
Sub-Investigator: Sinisa Markovic, MD         
Klinikum Landkreis Erding Recruiting
Erding, Bavaria, Germany, 85435
Contact: Lorenz Bott-Flügel, MD       lorenz.bott-fluegel@klinikum-erding.de   
Contact: Yvonne Anders, SN    +49 8122 591613    yvonne.anders@klinikum-erding.de   
Principal Investigator: Lorenz Bott-Flügel, MD         
Sub-Investigator: Nader Joghetaei, MD         
Deutsches Herzzentrum Munich Recruiting
München, Bavaria, Germany, 80636
Contact: Stefanie Schuepke, MD    +49-89-1218 ext 0    schuepke@dhm.mhn.dee   
Contact: Deborah-Ann Schuster    +49-89-1218 ext 1528    schuster@dhm.mhn.de   
Principal Investigator: Stefanie Schuepke, MD         
Sub-Investigator: Katharina Mayer, MD         
Klinikum rechts der Isar, 1. Medizinische Klinik und Poliklinik Recruiting
München, Bavaria, Germany, 81675
Contact: Isabell Bernlochner, MD    +49 89 4140 2350    isabell.bernlochner@mri.tum.de   
Principal Investigator: Karl-Ludwig Laugwitz, MD         
Sub-Investigator: Isabell Bernlochner, MD         
Klinikum Neuperlach Recruiting
München, Bavaria, Germany, 81737
Contact: Harald Mudra, MD    +49 89 6794-2351    harald.mudra@klinikum-muenchen.de   
Contact: Jacqueline Fiedler, SC    +49 89 6794 2353    jacqueline.fiedler@klinikum-muenchen.de   
Principal Investigator: Harald Mudra, MD         
Sub-Investigator: Manuela Segerer, MD         
Universitätsklinikum Regensburg Recruiting
Regensburg, Bavaria, Germany, 93042
Contact: Marcus Fischer, MD    +49 941 944-7299    marcus.fischer@ukr.de   
Contact: Ingrid Lugauer, SC    +49 941 944 7337    ingrid.lugauer@klinik.uni-regensburg.de   
Principal Investigator: Marcus Fischer, MD         
Sub-Investigator: Andrea Bässler, MD         
Klinikum Traunstein Active, not recruiting
Traunstein, Bavaria, Germany, 83278
Kerckhoff-Klinik GmbH, Abteilung für Kardiologie Recruiting
Bad Nauheim, Hessen, Germany, 61231
Contact: Helge Möllmann, MD    +49 6032 996-2202    h.moellmann@kerckhoff-klinik.de   
Contact: Heike Wagner, Study Nurse    +49 6032 996-5813    h.wagner@kerckhoff-forschungs-gmbh.de   
Principal Investigator: Helge Möllmann, MD         
Sub-Investigator: Christian Hamm, MD         
Universitätsmedizin Göttingen, Herzzentrum Recruiting
Göttingen, Niedersachsen, Germany, 37099
Contact: Claudius Jacobshagen, MD    +49 551-39-13239    jacobshagen@med.uni-goettingen.de   
Principal Investigator: Claudius Jacobshagen, MD         
Sub-Investigator: Wolfgang Schillinger, MD         
Herzzentrum Wuppertal Active, not recruiting
Wuppertal, Nordrhein-Westfalen, Germany, 42117
Segeberger Kliniken GmbH Recruiting
Bad Segeberg, Schleswig-Holstein, Germany, 23795
Contact: Gert Richardt, MD    +49 4551 802    gert.richardt@segebergerkliniken.de   
Contact: Daniela Schürmann-Kuchenbrand, Study Nurse    +49 4551 802 9947    daniela.schuermann-kuchenbrandt@segebergerkliniken.de   
Principal Investigator: Gert Richardt, MD         
Sub-Investigator: Ralph Ernst Tölg, MD         
Universitätsklinikum Schleswig-Holstein, Klinik für Innere Medizin III, Campus Kiel Not yet recruiting
Kiel, Schleswig-Holstein, Germany, 24105
Contact: Norbert Frey, MD         
Contact: Petra Röthgen, SC    +49 431 5971455    petra.roethgen@uk-sh.de   
Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin Recruiting
Berlin, Germany, 12203
Contact: Ulf Landmesser, MD       ulf.landmesser@charite.de   
Contact: Anne-Christin Krämer, SN       anne-christin.kraemer@charite.de   
Charité Universitätsmedizin Berlin, Campus Virchow-Klinik Recruiting
Berlin, Germany, 13353
Contact: Florian Krackhardt, MD       Florian.Krackhardt@charite.de   
Contact: Tina Gaulhofer, SC    +49 30 450 553 782    christina.gaulhofer@charite.de   
Italy
Careggi University Hospital, Invasive Cardiology Division Recruiting
Firenze, Italy, 50141
Contact: David Antoniucci, MD       david.antoniucci@virgilio.it   
Contact: Fabio Torrini, Assistant       cardiologia1@aou-careggi.toscana.it   
Principal Investigator: David Antoniucci, MD         
Spaziani Hospital Frosinone Recruiting
Frosinone, Italy, 03100
Contact: Maurizio Menichelli, MD    +39 3382642317    menichelli747@yahoo.com   
Principal Investigator: Maurizio Menichelli, MD         
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Investigators
Study Chair: Adnan Kastrati, MD Deutsches Herzzentrum München
Principal Investigator: Stefanie Schuepke, MD Deutsches Herzzentrum München
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT01944800     History of Changes
Other Study ID Numbers: GE IDE 00113
2013-002272-40 ( EudraCT Number )
First Posted: September 18, 2013    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017

Keywords provided by Deutsches Herzzentrum Muenchen:
Ticagrelor
Prasugrel
Acute coronary syndrome
Percutaneous coronary intervention

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ticagrelor
Prasugrel Hydrochloride
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Platelet Aggregation Inhibitors