Acute Coronary Syndromes, ST Elevation Myocardial Infarction
Conditions
Keywords
STEMI
Brief summary
To examine chewing versus traditional oral administration of ticagrelor in ST-elevation Myocardial Infarction (STEMI) patients on platelet reactivity.
Interventions
DRUGChewing Ticagrelor
180 mg Chewing Ticagrelor
DRUGOral Ticagrelor
180 mg oral Ticagrelor
Sponsors
Sheba Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD | 1 hour |
Secondary
| Measure | Time frame |
|---|---|
| The percent of patients with a high residual platelet reactivity (PRU > 208) 1 hour, 4-6 hours after ticagrelor LD | 1, 4-6 hours |
| Major, minor, minimal bleeding [ Thrombolysis in Myocardial Infarction (TIMI) criteria] events | 30 days |
| Occurrence of dyspnea and/or symptomatic bradycardia | 30 days |
Countries
Israel
Outcome results
None listed