Residual Platelet Activity Despite Aspirin Utilization in Coronary Heart Disease

Study Overview
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Brief Summary
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The purpose of this study is to compare the response to aspirin in the acute phase with the late phase of an acute coronary syndrome.

Detailed Description
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The purpose of this study is to compare, in the same population, the response to aspirin in the initial phase (first 48 hours) with the late phase (after 3 months of discharge)of a non ST elevation acute coronary syndrome (angina or acute myocardial infarction).

Official Title
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Residual Platelet Activity Despite Aspirin Utilization in Patients With Non ST Elevation Acute Coronary Syndromes: Comparison Between the Acute and Chronic Phases

Conditions
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Coronary Heart Disease, Non ST-elevation Acute Coronary Syndromes

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Confirmed diagnosis of acute coronary syndrome without ST segment elevation, in the first 48 hours after the onset of the clinical symptoms Regular use of aspirin for at least seven days. Exclusion Criteria: Previous use, in the last 7 days, of another antiplatelet agent than aspirin Use of antivitamin K in the last 3 weeks Hemoglobin < 10g/dL and / or hematocrit < 30% or > 50%, platelets count < 100.000/mm3 or > 500.000/mm3, creatinine clearance < 30 mL / minute Killip class III or IV Need for vasopressor or inotropic parenteral medication at inclusion in the study Percutaneous coronary intervention within 30 days or CABG in the last 90 days prior to study entry Current malignancy Hematologic diseases Refusal to sign the inform consent form Unable to attend the second visit (follow-up) for any reason except for death

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| First 48 hours<br>Patients in the first 48 hours of non ST-elevation acute coronary syndromes. | |
| 3 months after discharge<br>Patients with 3 months after hospital discharge for non ST-elevation acute coronary syndromes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare platelet aggregation between the first 48 hours and 3 months after discharge. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relation between platelet aggregability and the composite endpoint of death, myocardial infarction, unstable angina and need for revascularization or hospitalization at 3 months after discharge. |  | 3 months | 
| Relation between the atherosclerotic burden by coronary angiography with the platelet aggregation in the first 48 hours. |  | 48 hours | 
| Relation between C reactive protein and interleukin -6 with levels of platelet aggregation. |  | first 48 hours and 3 months | 
| Relation between platelet aggregation and the presence or absence of selected polymorphisms. |  | first 48 hours and 3 months | 
| Platelet aggregation in respect to age, gender, glucose at hospital arrival, glycated hemoglobin, statin, PPI, current smokers, ACE inhibitors, type of ACS presentation. | Cut point for age 65 y, for glycemia 125 mg/dL, for glycated hemoglobin 6% | first 48 hours and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platelet aggregation, Aspirin