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

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ClinicalTrials.gov Identifier: NCT02809820
Recruitment Status : Unknown
Verified June 2016 by Giovanni Esposito, Federico II University.
Recruitment status was:  Recruiting
First Posted : June 22, 2016
Last Update Posted : September 13, 2016
Sponsor:
Information provided by (Responsible Party):
Giovanni Esposito, 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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: Carvedilol Drug: Metoprolol Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Selective and Nonselective Beta-blockade on Platelet Aggregation in Patients With Acute Coronary Syndrome
Study Start Date : May 2016
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Non Selective beta-blocker




Primary Outcome Measures :
  1. Platelet aggregation [ Time Frame: 30 days ]
    Platelet aggregation induced by epinephrine is measured by Light Transmission Aggregometry (LTA)


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02809820


Contacts
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Contact: Giovanni Esposito, MD PhD 0817463075 ext 0039 espogiov@unina.it
Contact: Federica Ilardi, MD 0817462240 ext 0039 fedeilardi@gmail.com

Locations
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Italy
Federico II University of Naples Recruiting
Naples, Italy, 80131
Contact: Giovanni Esposito, MD PhD    0817463075 ext 0039    espogiov@unina.it   
Principal Investigator: Giovanni Esposito, MD PhD         
Sponsors and Collaborators
Federico II University
Investigators
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Principal Investigator: Giovanni Esposito, MD PhD Federico II University

Publications:
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Responsible Party: Giovanni Esposito, MD, PhD, Federico II University
ClinicalTrials.gov Identifier: NCT02809820    
Other Study ID Numbers: CE-9/14
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Giovanni Esposito, Federico II University:
ACS
Beta Blockers
platelet aggregation
light transmission aggregometry
Beta-Adrenergic Blockers
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Metoprolol
Carvedilol
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antioxidants
Protective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists