Sub Lingual Versus Traditional Oral Administration of Ticagrelor in Acute Coronary Syndrome/Non ST-elevation Myocardial Infarction - A Platelet Reactivity Study

Study Overview
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Brief Summary
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Our goal is to examine sub lingual versus traditional oral administration of ticagrelor in ACS/non ST-elevation Myocardial Infarction (NSTEMI) patients on platelet reactivity.

Official Title
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Sub Lingual Versus Traditional Oral Administration of Ticagrelor in Acute Coronary Syndrome

Conditions
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Acute Coronary Syndromes, Non ST Elevation Myocardial Infarction

Intervention / Treatment
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* Drug: Sub Lingual Ticagrelor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presenting with ACS/NSTEMI Informed, written consent Exclusion Criteria: Age < 18 years or Age > 90 years Active bleeding; bleeding diathesis; coagulopathy Increased risk of bradycardiac 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, 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

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: Sub Lingual Ticagrelor<br>* 180mg sub-lingual ticagrelor<br>|
| Experimental: Sub Lingual Ticagrelor<br> | Drug: Sub Lingual Ticagrelor<br>* 180mg sub-lingual 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 |  | 1hour | 

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, 12 hours after ticagrelor LD. |  | 1, 4-6, 12 hours | 
| Bleeding events: Major, minor, minimal bleeding (TIMI criteria) events. |  | 24 hours | 
| Occurrence of dyspnea and/or symptomatic bradycardia. |  | 24 hours | 

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