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



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:6/10/2016
Start Date:September 2013
End Date:October 2018
Contact:Stefanie Schulz, MD
Email:schulzS@dhm.mhn.de
Phone:+49-89-1218-

Use our guide to learn which trials are right for you!

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.


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 or transient ischemic attack

3. 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. platelet count < 100.000/μL at the time of screening

7. 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, CYP3A substrates with
narrow therapeutic indices or strong CYP3A inducers that cannot be safely
discontinued

16. ≥1 doses of ticagrelor or prasugrel within 5 days before randomisation

17. participation in another investigational drug study

18. previous enrolment in this study

19. pregnancy, giving birth within the last 90 days, or lactation

20. inability to cooperate with protocol requirements
We found this trial at
2
sites
Bad Krozingen, Baden-Württemberg 79189
Principal Investigator: Franz-Josef Neumann, MD
Phone: +49 7633 402-2000
?
mi
from
Bad Krozingen,
Click here to add this to my saved trials
Jacksonville, Florida 32209
Principal Investigator: Dominick Angiolillo, MD
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials