Effects of Beta-blockade on Platelet Aggregation in Acute Coronary Syndrome (PLATE-BLOCK)

March 15, 2022 updated by: Giovanni Esposito, Federico II University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80131
        • Federico II University of Naples

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Investigators

  • Principal Investigator: Giovanni Esposito, MD PhD, Federico II University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

June 20, 2016

First Submitted That Met QC Criteria

June 21, 2016

First Posted (Estimate)

June 22, 2016

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 15, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE-9/14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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