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

Phase 4

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Carvedilol; Drug: Metoprolol

• Registration Number: NCT02809820
• Lead Sponsor: Federico II University

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-06-20
• Study First Submitted QC: 2016-06-21
• Study First Posted: 2016-06-22
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-15
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carvedilol	Carvedilol	Patients who have documented ACS, who are on dual antiplatelet therapy and are randomized to assume carvedilol.
Metoprolol	Metoprolol	Patients who have documented ACS, who are on dual antiplatelet therapy and are randomized to assume metoprolol.

Primary Outcome Measures

Name	Time	Method
Platelet aggregation	30 days	Platelet aggregation induced by epinephrine is measured by Light Transmission Aggregometry (LTA)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Federico II University of Naples; 🇮🇹 Naples, Italy