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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 : Active, not recruiting
First Posted : September 18, 2013
Last Update Posted : July 16, 2019
Sponsor:
Collaborator:
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen

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

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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
Actual Study Start Date : September 15, 2013
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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


Locations
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Germany
Universitäts-Herzzentrum Freiburg/ Bad Krozingen
Bad Krozingen, Baden-Württemberg, Germany, 79189
Universitäts-Klinikum Heidelberg
Heidelberg, Baden-Württemberg, Germany, 69120
Universitätsklinikum Mannheim
Mannheim, Baden-Württemberg, Germany, 68167
Universitätsklinikum Ulm
Ulm, Baden-Württemberg, Germany, 89081
Klinikum Landkreis Erding
Erding, Bavaria, Germany, 85435
Deutsches Herzzentrum Munich
München, Bavaria, Germany, 80636
Klinikum rechts der Isar, 1. Medizinische Klinik und Poliklinik
München, Bavaria, Germany, 81675
Klinikum Neuperlach
München, Bavaria, Germany, 81737
Universitätsklinikum Regensburg
Regensburg, Bavaria, Germany, 93042
Klinikum Traunstein
Traunstein, Bavaria, Germany, 83278
Kerckhoff-Klinik GmbH, Abteilung für Kardiologie
Bad Nauheim, Hessen, Germany, 61231
Universitätsmedizin Göttingen, Herzzentrum
Göttingen, Niedersachsen, Germany, 37099
Herzzentrum Wuppertal
Wuppertal, Nordrhein-Westfalen, Germany, 42117
Segeberger Kliniken GmbH
Bad Segeberg, Schleswig-Holstein, Germany, 23795
Universitätsklinikum Schleswig-Holstein, Klinik für Innere Medizin III, Campus Kiel
Kiel, Schleswig-Holstein, Germany, 24105
Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin
Berlin, Germany, 12203
Charité Universitätsmedizin Berlin, Campus Virchow-Klinik
Berlin, Germany, 13353
Italy
Careggi University Hospital, Invasive Cardiology Division
Firenze, Italy, 50141
Spaziani Hospital Frosinone
Frosinone, Italy, 03100
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Investigators
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Study Chair: Adnan Kastrati, MD Deutsches Herzzentrum München
Principal Investigator: Stefanie Schuepke, MD Deutsches Herzzentrum München

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: July 16, 2019
Last Verified: July 2019
Keywords provided by Deutsches Herzzentrum Muenchen:
Ticagrelor
Prasugrel
Acute coronary syndrome
Percutaneous coronary intervention
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ticagrelor
Prasugrel Hydrochloride
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs