Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome

Acute Coronary Syndrome (ACS) Clinical Trial

— ISAR-REACT 5  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01944800
• Other study ID #: GE IDE 00113
• Secondary ID: 2013-002272-40
• Status: Completed
• Phase: Phase 4
• Start date: September 15, 2013
• Est. completion date: September 2021

Study information

• Verified date: February 2023
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4018
• Est. completion date: September 2021
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndrome (ACS)
• Syndrome

Intervention

Drug:
• Ticagrelor
Loading dose of 180 mg, followed by maintenance dose of 180 mg per day
• 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

Locations

Country	Name	City	State
Germany	Universitäts-Herzzentrum Freiburg/ Bad Krozingen	Bad Krozingen	Baden-Württemberg
Germany	Kerckhoff-Klinik GmbH, Abteilung für Kardiologie	Bad Nauheim	Hessen
Germany	Segeberger Kliniken GmbH	Bad Segeberg	Schleswig-Holstein
Germany	Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin	Berlin
Germany	Charité Universitätsmedizin Berlin, Campus Virchow-Klinik	Berlin
Germany	Klinikum Landkreis Erding	Erding	Bavaria
Germany	Universitätsmedizin Göttingen, Herzzentrum	Göttingen	Niedersachsen
Germany	Universitäts-Klinikum Heidelberg	Heidelberg	Baden-Württemberg
Germany	Universitätsklinikum Schleswig-Holstein, Klinik für Innere Medizin III, Campus Kiel	Kiel	Schleswig-Holstein
Germany	Universitätsklinikum Mannheim	Mannheim	Baden-Württemberg
Germany	Deutsches Herzzentrum Munich	München	Bavaria
Germany	Klinikum Neuperlach	München	Bavaria
Germany	Klinikum rechts der Isar, 1. Medizinische Klinik und Poliklinik	München	Bavaria
Germany	Universitätsklinikum Regensburg	Regensburg	Bavaria
Germany	Klinikum Traunstein	Traunstein	Bavaria
Germany	Universitätsklinikum Ulm	Ulm	Baden-Württemberg
Germany	Herzzentrum Wuppertal	Wuppertal	Nordrhein-Westfalen
Italy	Careggi University Hospital, Invasive Cardiology Division	Firenze
Italy	Spaziani Hospital Frosinone	Frosinone

Sponsors (2)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen	Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Countries where clinical trial is conducted

Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of death, myocardial infarction or stroke		12 months
Secondary	Bleeding	Bleeding according to BARC	12 months
Secondary	Mortality	Death for any cause	12 months
Secondary	Stroke	Stroke	12 months
Secondary	Myocardial Infarction		12 months
Secondary	Stent Thrombosis	Stent thrombosis according to ARC	12 months