Mechanistic Study of Bleeding Risk in Coronary Patients With Cerebrovascular Disease

Study Overview
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Brief Summary
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Background: About 5% of patients with acute coronary syndrome (ACS) have had previously ischemic stroke (IS) or transitory ischemic attack (TIA). This is a high-risk population, with a high incidence of ischemic events, and also of bleeding events. While the high ischemic risk in this population is attributed to a higher prevalence of cardiovascular risk factors, their predisposition to bleeding events is not well understood. Hypothesis: The increased bleeding risk in ACS patients with history of cerebrovascular event may be justified by a low platelet activity. Methods: Unicentric, prospective, case-control study, which included approximately 100 post-ACS patients with history of IS/TIA previously to the acute coronary event (Case Group) and 100 patients without IS/TIA (Control group). The groups were matched for gender, age, and ACS type and year of occurrence. All patients were taking aspirin, and the main exclusion criteria were use of dual antiplatelet therapy, previous hemorrhagic stroke, severe renal dysfunction, thrombocytopenia or coagulopathy. Main analysis: Platelet aggregation was evaluated by 6 methods: VerifyNow Aspirin®, VerifyNow P2Y12®, PFA 100®, thrombelastography (ReoRox®), light transmission aggregometry with ADP (LTA ADP) and epinephrine (LTA EPI) as agonists. Additional analysis: genetic, HDL transport and inflammatory evaliation

Official Title
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Mechanisms Involved in the Bleeding Risk of Patients With Coronary Artery Diseased Previous Stroke or Transient Ischemic Attack in Use of Antiplatelet Therapy

Conditions
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Coronary Artery Disease, Cerebral Stroke, TIA (Transient Ischemic Attack)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Post-ACS patients with history of IS/TIA previously to the acute coronary event and taking aspirin Sign the consent form Exclusion Criteria: Hemorrhagic stroke Another antiplatelet drug than aspirin Use of Anti inflammatory drug Severe chronic kidney dysfunction Liver disease Coagulopathy Platelet disfunction Thrombocytopenia or thrombocytosis Refuse to sign the consent form

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 |
| --- | --- |
| Control group<br>Post-ACS patients without history of IS/TIA previously to the acute coronary and taking aspirin | |
| Case group<br>Post ACS patients with history of IS/TIA previously to the acute coronary event and taking aspirin | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual platelet activity by VerifyNow Aspirin (Aspirin reactivity units) |  | in the selection visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline platelet activity by VerifyNow P2Y12 (P2Y12 reactivity units) |  | in the selection visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bleeding risk, acute coronary syndrome, platelet agregation,