Chewed Versus Integral Pill of Ticagrelor

Study Overview
=================
Brief Summary
-----------------
Hypothesis The primary question the investigators propose to answer is whether all patients undergoing percutaneous coronary intervention (PCI) with stent deployment who receive chewed ticagrelor will demonstrate more rapid drug absorption and decreased platelet reactivity as compared to integral pill form 1 hour after drug administration.

Detailed Description
-----------------
Hypothesis The primary question the investigators propose to answer is whether all patients undergoing PCI with stent deployment who receive chewed ticagrelor will demonstrate more rapid drug absorption and decreased platelet reactivity as compared to integral pill form 1 hour after drug administration. Secondary Hypotheses: Major adverse cardiac and cerebrovascular event (MACCE) rate at 30 days and 1 year. Death Repeat myocardial infarction Need for urgent revascularization Cerebrovascular accident Rate of stent thrombosis and in-stent stenosis at 30 days and 1 year. Bleeding: Defined as major, minor, or minimal bleeding based on thrombolysis in myocardial infarction (TIMI) criteria.

Official Title
-----------------
Chewed Versus Integral Pill of Ticagrelor in All Patients Undergoing Percutaneous Coronary intervention--a Platelet Reactivity and Patient Outcomes Study.

Conditions
-----------------
Percutaneous Coronary Intervention

Intervention / Treatment
-----------------
* Drug: Ticagrelor
* Drug: Ticagrelor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • All patients presenting to the cardiac catheterization lab for percutaneous coronary intervention. Exclusion Criteria: Age <18 years or Age >89 years Known coagulopathy, bleeding diathesis, or active bleeding History of recent gastrointestinal or genitourinary bleed within 2 months Known chronic therapy with clopidogrel, prasugrel, or ticagrelor Major surgery within last 6 weeks History of intracranial bleed or intracranial neoplasm Suspected aortic dissection Severe hemodynamic instability, cardiogenic shock Life expectancy <1 year Known severe liver or renal disease Known HIV treatment Any use of Glycoprotein inhibitors (GP IIb-IIIa) 48-hours before the procedure or any use during the procedure Any use of Cangrelor during or after the procedure Hemoglobin <10 g/dL, platelet (PLT) <100x10^9/L Pregnancy Known allergy to study medication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Chewed ticagrelor<br>Drug: Ticagrelor chewed pills. The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline P2Y12 platelet reaction units (PRU) level is drawn and before the end of the PCI. Patients will be asked to chew, but not swallow, allowing for sublingual absorption. (Loading dose 180mg) | Drug: Ticagrelor<br>* Chewed<br>* Other names: Possia;|
| Active Comparator: Active Comparator: Integral pill<br>Drug: Ticagrelor integral pills. The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline P2Y12 platelet reaction units (PRU) level is drawn and before the end of the PCI. Patients will swallow the loading dose followed by 25-50mL (milliliter) of water. (180mg) | Drug: Ticagrelor<br>* Integral<br>* Other names: Possia;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of Pharmacodynamics | Platelet function was measured using the VerifyNow P2Y12 Assay (Accumetrics, San Diego, CA). This test is a turbidimetric-based optical detection system that measures ADP (Adenosine diphosphate) - induced platelet agglutination using a proprietary algorithm to report values in PRU. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Major Adverse Cardiac and Cerebrovascular Event (MACCE) | Measure events such as: death, repeat myocardial revascularization, cerebrovascular accident, stent thrombosis, in-stent stenosis and bleeding. | 30 days | 
| Number of Participants With Major Adverse Cardiac and Cerebrovascular Event (MACCE) | Measure events such as: death, repeat myocardial revascularization, cerebrovascular accident, stent thrombosis, in-stent stenosis and bleeding. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ticagrelor, Stent