Overview

Chewing Versus Traditional Oral Administration of Ticagrelor in STEMI Patients

Status:
Completed
Trial end date:
2017-01-01
Target enrollment:
0
Participant gender:
All
Summary
To examine chewing versus traditional oral administration of ticagrelor in ST-elevation Myocardial Infarction (STEMI) patients on platelet reactivity.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sheba Medical Center
Treatments:
Ticagrelor
Criteria
Inclusion Criteria:

1. Patients presenting with STEMI

2. Informed, written consent

Exclusion Criteria:

1. Age < 18 years or Age > 90 years

2. Active bleeding; bleeding diathesis; coagulopathy

3. Increased risk of bradycardic events

4. History of gastrointestinal or genitourinary bleeding <2 months

5. Major surgery in the last 6 weeks

6. History of intracranial bleeding or structural abnormalities

7. Suspected aortic dissection

8. Any other condition that may put the patient at risk or influence study results or
investigator's opinion (severe hemodynamic instability, unconsciousness, known
malignancies or other comorbid conditions with life expectancy <1 year)

9. Administration in the week before the index event of clopidogrel, ticlopidine,
prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or
fondaparinux.

10. Concomitant oral or IV therapy with strong CYP3A inhibitors or strong CYP3A inducers,
CYP3A with narrow therapeutic windows

11. Known relevant hematological deviations: Hb <10 g/dl, PLT<100x10^9/l

12. Use of coumadin derivatives within the last 7 days

13. Chronic therapy with ticagrelor, prasugrel, clopidogrel or ticlopidine

14. Known severe liver disease, severe renal failure

15. Known allergy to the study medications

16. Pregnancy

17. Human immunodeficiency virus treatment

18. The use of IIBIIIA receptor antagonists in the 48 hours before enrollment (if
abciximab use then in the last 14 days).

19. If the patients cannot sign percutaneous coronary intervention (PCI) informed consent
for any reason.