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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

Tracking Information
First Submitted Date  ICMJE September 13, 2013
First Posted Date  ICMJE September 18, 2013
Last Update Posted Date July 16, 2019
Actual Study Start Date  ICMJE September 15, 2013
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2013)
Composite of death, myocardial infarction or stroke [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01944800 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2013)
  • Bleeding [ Time Frame: 12 months ]
    Bleeding according to BARC
  • Mortality [ Time Frame: 12 months ]
    Death for any cause
  • Stroke [ Time Frame: 12 months ]
    Stroke
  • Myocardial Infarction [ Time Frame: 12 months ]
  • Stent Thrombosis [ Time Frame: 12 months ]
    Stent thrombosis according to ARC
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Coronary Syndrome (ACS)
Intervention  ICMJE
  • Drug: Ticagrelor
    Loading dose of 180 mg, followed by maintenance dose of 180 mg per day
    Other Name: Brilique
  • 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
Study Arms  ICMJE
  • Experimental: Ticagrelor
    Intervention: Drug: Ticagrelor
  • Active Comparator: Prasugrel
    Intervention: Drug: Prasugrel
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 13, 2013)
4000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Italy
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01944800
Other Study ID Numbers  ICMJE GE IDE 00113
2013-002272-40 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Deutsches Herzzentrum Muenchen
Study Sponsor  ICMJE Deutsches Herzzentrum Muenchen
Collaborators  ICMJE Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Investigators  ICMJE
Study Chair: Adnan Kastrati, MD Deutsches Herzzentrum München
Principal Investigator: Stefanie Schuepke, MD Deutsches Herzzentrum München
PRS Account Deutsches Herzzentrum Muenchen
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP