Chewing Versus Traditional Oral Administration of Ticagrelor in STEMI Patients

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

Official Title
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Chewing Versus Traditional Oral Administration of Ticagrelor in ST-elevation Myocardial Infarction Patients - A Platelet Reactivity Study

Conditions
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Acute Coronary Syndromes, ST Elevation Myocardial Infarction

Intervention / Treatment
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* Drug: Chewing Ticagrelor
* Drug: Oral Ticagrelor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presenting with STEMI Informed, written consent Exclusion Criteria: Age < 18 years or Age > 90 years Active bleeding; bleeding diathesis; coagulopathy Increased risk of bradycardic events History of gastrointestinal or genitourinary bleeding <2 months Major surgery in the last 6 weeks History of intracranial bleeding or structural abnormalities Suspected aortic dissection 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) Administration in the week before the index event of clopidogrel, ticlopidine, prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux. Concomitant oral or IV therapy with strong CYP3A inhibitors or strong CYP3A inducers, CYP3A with narrow therapeutic windows Known relevant hematological deviations: Hb <10 g/dl, PLT<100x10^9/l Use of coumadin derivatives within the last 7 days Chronic therapy with ticagrelor, prasugrel, clopidogrel or ticlopidine Known severe liver disease, severe renal failure Known allergy to the study medications Pregnancy Human immunodeficiency virus treatment The use of IIBIIIA receptor antagonists in the 48 hours before enrollment (if abciximab use then in the last 14 days). If the patients cannot sign percutaneous coronary intervention (PCI) informed consent for any reason.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral Ticagrelor<br> | Drug: Oral Ticagrelor<br>* 180 mg oral Ticagrelor<br>|
| Experimental: Chewing Ticagrelor<br> | Drug: Chewing Ticagrelor<br>* 180 mg Chewing Ticagrelor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD |  | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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STEMI