Platelet Reactivity Inhibition Following Ticagrelor Loading Dose and One Year Outcome

Study Overview
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Brief Summary
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This study will try to determine if the measure of the platelet reactivity of the patients receiving from the ticagrelor continuation in an acute coronary syndrome handled by coronary angioplasty allows to predict the hemorrhagic risk.

Detailed Description
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The use of thienopyridines in patients undergoing percutaneous coronary intervention (PCI) has dramatically decreased the rate of early stent thrombosis. Further the CURE trial demonstrated that long-term clopidogrel decreases the rate of major adverse cardiovascular events in acute coronary syndrome patients (ACS) . However clopidogrel has several limitations including a long delay of action which is a potential limitation in acute settings of coronary artery disease. Another major limitation of the drug is the wide inter individual variability in clopidogrel responsiveness related to various factors. In addition recent studies suggested that platelet reactivity inhibition does also determine the bleeding risk. The ticagrelor is a new blocker of the receiver P2Y12 which distinguishes itself from the clopidogrel by a superior biological efficiency. This biological property was translated in the study PLATO, having compared it with the clopidogrel in the ACS, by a reduction of the risk thrombotique. The ticagrelor is thus recommended in first intention in this indication. There seems be a variability of answer to the ticagrelor. Besides the ticagrelor infers a level of intense platelet inhibition which could explain on hemorrhagic risk which is associated with it.

Official Title
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Platelet Reactivity Inhibition Following Ticagrelor Loading Dose and One Year Outcome in Patients Undergoing Percutaneous Coronary Intervention for an Acute Coronary Syndrome

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Other: blood sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute coronary syndrome patient undergoing PCI and eligible for ticagrelor therapy according to the guidelines. Exclusion criteria: New York Heart Association functional class III or IV Cardiac arrest Contra-indications to antiplatelet therapy Platelet count <100 G/l History of bleeding diathesis Concurrent severe illness with expected survival of < 1 year month Pregnant of childbearing woman Inability to provide an informed consent Contra indication to ticagrelor.

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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acute coronary syndrome patient<br>Acute coronary syndrome patient undergoing PCI and eligible for ticagrelor therapy according to the guidelines accepting blood samples measuring platelets reactivity | Other: blood sample<br>* Biological samples will be done to determine platelet reactivity testing by VASP-index, will be obtained between 6 and 12 hours after receiving ticagrelor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet reactivity inhibition measured by the VASP index 6 to 12 hours after the loading dose of ticagrelor | Platelet reactivity inhibition measured by the VASP index 6 to 12 hours after the loading dose is associated with the occurrence of BARC bleedings ≥ 2 at one year post-PCI. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between VASP index and MACE | the rate of major cardiovascular events ( MACE ) | 1 month | 
| Relationship between VASP index and MACE |  | 1 year | 
| Relationship between VASP index and BARC | BARC: bleeding academic research complications | 1month | 
| Compliance to ticagrelor |  | 1 year | 
| Evaluate Adenosine deaminase |  | 1 year | 
| evaluate DDP IV activity |  | 1 year | 
| Evaluate microparticules number and activity under ticagrelor |  | 1 year |