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The purpose of this study is to assess:
Ticagrelor is an anti-platelet agent of the cyclopentyltriazolopyrimidine class. It is administered by the oral route, rapidly absorbed (2-3 hours), and has a bio-availability estimated at around 36%. Contrary to other P2Y12 inhibitors, ticagrelor is not a pro-drug and does not need to be metabolized to exert is pharmacodynamic effect. It had been previously showed that stimulation of platelets by ADP or inhibitors of platelets by ticagrelor modified the organisation of the platelet membrane, with a re-distribution of cholesterol and P2Y12 receptors towards the lipid rafts. This suggests that lipid membranes and cholesterol may play an important role in the anti-platelet activity of ticagrelor.
In this context, the aim of the study is to assess:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study cohort | Adult (>18 years, <90 years) patients admitted and treated for acute myocardial infarction, and whose treatment includes ticagrelor in association with aspirin. Blood samples will be taken at 3 timepoints between two doses of ticagrelor (taken at 12 hours interval). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample | Other | 3 blood samples, for a maximum of 60mL, will be taken at 0-3h, 3-6h and >6h, between two doses of ticagrelor (taken at 0 and 12 hours). |
|
| Measure | Description | Time Frame |
|---|---|---|
| concentration of unbound ticagrelor and its metabolite | Concentration of unbound ticagrelor and its active metabolite in acute coronary syndrome patients treated by ticagrelor and aspirin | at 3 hours after administration of the first dose of ticagrelor |
| concentration of unbound ticagrelor and its metabolite | Concentration of unbound ticagrelor and its active metabolite in acute coronary syndrome patients treated by ticagrelor and aspirin | at 6 hours after administration of the first dose of ticagrelor |
| concentration of unbound ticagrelor and its metabolite | Concentration of unbound ticagrelor and its active metabolite in acute coronary syndrome patients treated by ticagrelor and aspirin | at 12 hours after administration of the first dose of ticagrelor |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the method of determination of ticagrelor concentration | Identify the optimum settings for the measurement of the concentration of ticagrelor (total and free fraction) and its active metabolite in the plasma by LC-MS/MS | at 3 hours after administration of the first dose of ticagrelor |
| Assess the method of determination of ticagrelor concentration |
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Inclusion Criteria:
Exclusion Criteria:
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Patients admitted to the Cardiology department with a main diagnosis of acute coronary syndrome and treated with a treatment combination including ticagrelor and aspirin.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Lagoutte-Renosi, MPharm | Contact | +33370632379 | jlagoutte@chu-besancon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Nicolas Meneveau, MD, PhD | Dept of Cardiology, CHU Besancon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Besançon | Recruiting | Besançon | 25000 | France |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Identify the optimum settings for the measurement of the concentration of ticagrelor (total and free fraction) and its active metabolite in the plasma by LC-MS/MS |
| at 6 hours after administration of the first dose of ticagrelor |
| Assess the method of determination of ticagrelor concentration | Identify the optimum settings for the measurement of the concentration of ticagrelor (total and free fraction) and its active metabolite in the plasma by LC-MS/MS | at 12 hours after administration of the first dose of ticagrelor |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |