Effects of Beta-blockade on Platelet Aggregation in Acute Coronary Syndrome

Study Overview
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Brief Summary
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The Investigators will test the hypothesis that nonselective beta-blockers would have a more pronounced effect on platelet aggregation than selective beta-blockers in patients with acute coronary syndrome treated with dual anti platelet therapy.

Detailed Description
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In patients with acute coronary syndrome (ACS) beta-blockers are recommended for secondary prevention. It is known that catecholamine levels can potentiate platelet reactivity and beta-blocking agents may also affect platelet aggregation. This effect is mainly mediated by adrenergic receptors on platelets. This suggests that nonselective beta-blockers would have a more pronounced effect on platelet aggregation than selective beta-blockers. However, little is known about the effect of beta-blockers on platelet aggregation in patients with cardiovascular disease and, to date, nothing is known in the setting of ACS. The aim of the present study is to evaluate the effect of selective and nonselective beta-blockers on platelet aggregation in ACS patients treated with dual anti platelet therapy.

Official Title
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Effects of Selective and Nonselective Beta-blockade on Platelet Aggregation in Patients With Acute Coronary Syndrome

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: Carvedilol
* Drug: Metoprolol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute Coronary Syndrome Current dual anti platelet treatment with acetylsalicylic acid and Ticagrelor Exclusion Criteria: ongoing prasugrel, ticlopidine or clopidogrel therapy Creatinine Clearance < 30 ml/min/1.73mm2 Moderate to severe anemia Hemoglobin < 10 mg/dl Platelet count >600000/mm3 or <150000/mm3 or hematocrit >50% or <25% concomitant neoplastic or immune-mediated pathologies severe pulmonary pathologies contraindication to beta blocker therapy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Carvedilol<br>Patients who have documented ACS, who are on dual antiplatelet therapy and are randomized to assume carvedilol. | Drug: Carvedilol<br>* Patients randomized to this group will receive carvedilol at the highest dose tolerated<br>* Other names: Selective beta-blocker;|
| Active Comparator: Metoprolol<br>Patients who have documented ACS, who are on dual antiplatelet therapy and are randomized to assume metoprolol. | Drug: Metoprolol<br>* Patients randomized to this group will receive metoprolol at the highest dose tolerated<br>* Other names: Non Selective beta-blocker;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet aggregation | Platelet aggregation induced by epinephrine is measured by Light Transmission Aggregometry (LTA) | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-days platelet aggregation | Platelet aggregation induced by Adenosine Diphosphate (ADP) is measured by Light Transmission Aggregometry (LTA) | 30 days | 
| 30-days clinical events | Major adverse cardiac events (MACE) and bleedings will be evaluated | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACS, Beta Blockers, platelet aggregation, light transmission aggregometry, Beta-Adrenergic Blockers