Pharmacodynamic Evaluation of Antiplatelet Effect of Swallowing Versus Chewing Ticagrelor in Patients With Acute Coronary Syndrome

Study Overview
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Brief Summary
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The study aims to determine the pharmacodynamic performance in the first hour measured with verifynow, of the conventional ticagrelor loaded dose versus chewed ticagrelor in patients with acute coronary syndrome treated with percutaneous coronary intervention

Official Title
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Pharmacodynamic Evaluation of Antiplatelet Effect of Swallowing Versus Chewing Ticagrelor in Patients With Acute Coronary Syndrome

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: Chewed ticagrelor
* Drug: Swallowed ticagrelor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients presenting to the emergency department with acute coronary syndrome for percutaneous coronary intervention Exclusion Criteria: Age <18 years Known coagulopathy, bleeding diathesis, or active bleeding History of recent gastrointestinal or genitourinary bleeding within 2 months Previous therapy with clopidogrel, prasugrel, or ticagrelor Previous treatment with glycoprotein IIb/IIIa inhibitors or during interventional procedure Major surgery within 6 weeks History of intracranial bleeding or intracraneal neoplasm Suspected aortic dissection Chronic obstructive pulmonary disease Severe hemodynamic instability or cardiogenic shock Resuscitated cardiac arrest Use of vitamin K anticoagulants or novel oral anticoagulants (NOACs) within 7 days Life expectancy <1 year Known severe liver or renal disease, GFR estimated by CKD-EPI <30 ml/min/1.73 m2 Known HIV treatment Hemoglobin <10 g/dL Platelet count <100,000/L Pregnancy Known allergy to ticagrelor Refusal to sign informed consent

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 85 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 |
| --- | --- |
| Experimental: Chewed ticagrelor<br>Ticagrelor pills. The 180 mg loading dose will be administered as soon as possible by investigation staff after a baseline VerifyNow measurement and after signed informed consent. Patients will be asked to chew, but not to swallow, during at least 40 seconds in presence of investigation staff. Drug: ticagrelor (Brilinta) 90 mg tablets, 2 tablets chewed | Drug: Chewed ticagrelor<br>* Chewed ticagrelor (Brilinta) 90 mg tablets, 2 tablets<br>|
| Active Comparator: Swallowed ticagrelor<br>Ticagrelor integral tablet. The 180 mg loading dose will be administered as soon as possible by investigation staff after a baseline VerifyNow measurement is drawn. Patients will swallow the loading dose followed by 25-40 ml of water. Drug: ticagrelor (Brilinta) 90 mg tableta, 2 tablets swallowed | Drug: Swallowed ticagrelor<br>* Swallowed ticagrelor (Brilinta) 90 mg tablets, 2 tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet reactivity | Platelet reactivity measured with VerifyNow (PRU) | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy (MACCE) | Composite outcome: made by major adverse cardiac and cerebrovascular events: all-cause death, repeat myocardial revascularization, stroke, myocardial infarction | 30 days | 
| Composite outcome | Composite outcome: major bleeding, AND nonmajor clinically relevant (NMCR) bleeding both by ISTH definition | 30 days | 
| Efficacy (long term) | Composite outcome: number of participants with major adverse cardiac and cerebrovascular events (MACCE) (previously defined) | 1 year | 
| High platelet reactivity on treatment rate | Inhibition of platelet aggregation (IPA) measured by VerifyNow | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ticagrelor, Platelet aggregation inhibitors, VerifyNow, Acute coronary syndrome