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

February 3, 2023 updated by: Deutsches Herzzentrum Muenchen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4018

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 12203
        • Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin
      • Berlin, Germany, 13353
        • Charité Universitätsmedizin Berlin, Campus Virchow-Klinik
    • Baden-Württemberg
      • Bad Krozingen, Baden-Württemberg, Germany, 79189
        • Universitäts-Herzzentrum Freiburg/ Bad Krozingen
      • Heidelberg, Baden-Württemberg, Germany, 69120
        • Universitäts-Klinikum Heidelberg
      • Mannheim, Baden-Württemberg, Germany, 68167
        • Universitätsklinikum Mannheim
      • Ulm, Baden-Württemberg, Germany, 89081
        • Universitatsklinikum Ulm
    • Bavaria
      • Erding, Bavaria, Germany, 85435
        • Klinikum Landkreis Erding
      • München, Bavaria, Germany, 80636
        • Deutsches Herzzentrum Munich
      • München, Bavaria, Germany, 81675
        • Klinikum rechts der Isar, 1. Medizinische Klinik und Poliklinik
      • München, Bavaria, Germany, 81737
        • Klinikum Neuperlach
      • Regensburg, Bavaria, Germany, 93042
        • Universitätsklinikum Regensburg
      • Traunstein, Bavaria, Germany, 83278
        • Klinikum Traunstein
    • Hessen
      • Bad Nauheim, Hessen, Germany, 61231
        • Kerckhoff-Klinik GmbH, Abteilung für Kardiologie
    • Niedersachsen
      • Göttingen, Niedersachsen, Germany, 37099
        • Universitätsmedizin Göttingen, Herzzentrum
    • Nordrhein-Westfalen
      • Wuppertal, Nordrhein-Westfalen, Germany, 42117
        • Herzzentrum Wuppertal
    • Schleswig-Holstein
      • Bad Segeberg, Schleswig-Holstein, Germany, 23795
        • Segeberger Kliniken Gmbh
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Universitätsklinikum Schleswig-Holstein, Klinik für Innere Medizin III, Campus Kiel
  • Italy
      • Firenze, Italy, 50141
        • Careggi University Hospital, Invasive Cardiology Division
      • Frosinone, Italy, 03100
        • Spaziani Hospital Frosinone

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ticagrelor
Drug: Ticagrelor
Loading dose of 180 mg, followed by maintenance dose of 180 mg per day
Other Names:
  • 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 Names:
  • Efient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite of death, myocardial infarction or stroke
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial Infarction
Time Frame: 12 months
12 months
Bleeding
Time Frame: 12 months
Bleeding according to BARC
12 months
Mortality
Time Frame: 12 months
Death for any cause
12 months
Stroke
Time Frame: 12 months
Stroke
12 months
Stent Thrombosis
Time Frame: 12 months
Stent thrombosis according to ARC
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deutsches Herzzentrum Muenchen

Collaborators

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 15, 2013

Primary Completion (ACTUAL)

July 1, 2019

Study Completion (ACTUAL)

September 1, 2021

Study Registration Dates

First Submitted

September 13, 2013

First Submitted That Met QC Criteria

September 13, 2013

First Posted (ESTIMATE)

September 18, 2013

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2023

Last Update Submitted That Met QC Criteria

February 3, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GE IDE 00113
  • 2013-002272-40 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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