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Clinical Trials/NCT02809820
NCT02809820
Completed
Phase 4

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

Federico II University1 site in 1 country100 target enrollmentMay 2016

Overview

Phase
Phase 4
Intervention
Carvedilol
Conditions
Acute Coronary Syndrome
Sponsor
Federico II University
Enrollment
100
Locations
1
Primary Endpoint
Platelet aggregation
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2016
End Date
December 2016
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Federico II University
Responsible Party
Principal Investigator
Principal Investigator

Giovanni Esposito

MD, PhD

Federico II University

Eligibility Criteria

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.

Arms & Interventions

Carvedilol

Patients who have documented ACS, who are on dual antiplatelet therapy and are randomized to assume carvedilol.

Intervention: Carvedilol

Metoprolol

Patients who have documented ACS, who are on dual antiplatelet therapy and are randomized to assume metoprolol.

Intervention: Metoprolol

Outcomes

Primary Outcomes

Platelet aggregation

Time Frame: 30 days

Platelet aggregation induced by epinephrine is measured by Light Transmission Aggregometry (LTA)

Secondary Outcomes

  • 30-days clinical events(30 days)
  • 30-days platelet aggregation(30 days)

Study Sites (1)

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