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Completed

NCT Number: NCT02809820

Effects of Beta-blockade on Platelet Aggregation in 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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Federico II University of Naples

Naples, 80131, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Carvedilol

Drug

Patients randomized to this group will receive carvedilol at the highest dose tolerated

Other names: Selective beta-blocker

metoprolol

Drug

Patients randomized to this group will receive metoprolol at the highest dose tolerated

Other names: Non Selective beta-blocker

Primary outcomes

  1. Platelet aggregation

    Time frame: 30 days

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

Secondary outcomes

  1. 30-days platelet aggregation

    Time frame: 30 days

    Platelet aggregation induced by Adenosine Diphosphate (ADP) is measured by Light Transmission Aggregometry (LTA)

  2. 30-days clinical events

    Time frame: 30 days

    Major adverse cardiac events (MACE) and bleedings will be evaluated

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Acronym: PLATE-BLOCK

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 22, 2016
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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