Clinical trial NCT02725099: Chewing Versus Traditional Oral Administration of Ticagrelor in STEMI Patients
Official title: Chewing Versus Traditional Oral Administration of Ticagrelor in ST-elevation Myocardial Infarction Patients - A Platelet Reactivity Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Coronary Syndromes
ST Elevation Myocardial Infarction
Keywords: STEMI
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-03-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To examine chewing versus traditional oral administration of ticagrelor in ST-elevation Myocardial Infarction (STEMI) patients on platelet reactivity.


Eligibility 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.

Primary outcomes:
measure: Residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD
timeFrame: 1 hour
Secondary outcomes:
measure: The percent of patients with a high residual platelet reactivity (PRU > 208) 1 hour, 4-6 hours after ticagrelor LD
timeFrame: 1, 4-6 hours
measure: Major, minor, minimal bleeding [ Thrombolysis in Myocardial Infarction (TIMI) criteria] events
timeFrame: 30 days
measure: Occurrence of dyspnea and/or symptomatic bradycardia
timeFrame: 30 days
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical center
Study officials:
References:
citation: Asher E, Tal S, Mazin I, Abu-Much A, Sabbag A, Katz M, Regev E, Chernomordik F, Guetta V, Segev A, Elian D, Barbash I, Fefer P, Narodistky M, Beigel R, Matetzky S. Effect of Chewing vs Swallowing Ticagrelor on Platelet Inhibition in Patients With ST-Segment Elevation Myocardial Infarction: A Randomized Clinical Trial. JAMA Cardiol. 2017 Dec 1;2(12):1380-1384. doi: 10.1001/jamacardio.2017.3868.