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

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Carvedilol
Metoprolol
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Acute Coronary Syndrome focused on measuring ACS, Beta Blockers, platelet aggregation, light transmission aggregometry, Beta-Adrenergic Blockers

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Federico II University of Naples

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Carvedilol

Metoprolol

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 20, 2016
Last Updated
March 15, 2022
Sponsor
Federico II University
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1. Study Identification

Unique Protocol Identification Number
NCT02809820
Brief Title
Effects of Beta-blockade on Platelet Aggregation in Acute Coronary Syndrome
Acronym
PLATE-BLOCK
Official Title
Effects of Selective and Nonselective Beta-blockade on Platelet Aggregation in Patients With Acute Coronary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
ACS, Beta Blockers, platelet aggregation, light transmission aggregometry, Beta-Adrenergic Blockers

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carvedilol
Arm Type
Active Comparator
Arm Description
Patients who have documented ACS, who are on dual antiplatelet therapy and are randomized to assume carvedilol.
Arm Title
Metoprolol
Arm Type
Active Comparator
Arm Description
Patients who have documented ACS, who are on dual antiplatelet therapy and are randomized to assume metoprolol.
Intervention Type
Drug
Intervention Name(s)
Carvedilol
Other Intervention Name(s)
Selective beta-blocker
Intervention Description
Patients randomized to this group will receive carvedilol at the highest dose tolerated
Intervention Type
Drug
Intervention Name(s)
Metoprolol
Other Intervention Name(s)
Non Selective beta-blocker
Intervention Description
Patients randomized to this group will receive metoprolol at the highest dose tolerated
Primary Outcome Measure Information:
Title
Platelet aggregation
Description
Platelet aggregation induced by epinephrine is measured by Light Transmission Aggregometry (LTA)
Time Frame
30 days
Secondary Outcome Measure Information:
Title
30-days platelet aggregation
Description
Platelet aggregation induced by Adenosine Diphosphate (ADP) is measured by Light Transmission Aggregometry (LTA)
Time Frame
30 days
Title
30-days clinical events
Description
Major adverse cardiac events (MACE) and bleedings will be evaluated
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni Esposito, MD PhD
Organizational Affiliation
Federico II University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federico II University of Naples
City
Naples
ZIP/Postal Code
80131
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24730697
Citation
Bonten TN, Plaizier CE, Snoep JJ, Stijnen T, Dekkers OM, van der Bom JG. Effect of beta-blockers on platelet aggregation: a systematic review and meta-analysis. Br J Clin Pharmacol. 2014 Nov;78(5):940-9. doi: 10.1111/bcp.12404.
Results Reference
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PubMed Identifier
25868659
Citation
Ignjatovic V, Pavlovic S, Miloradovic V, Andjelkovic N, Davidovic G, Djurdjevic P, Stolic R, Iric-Cupic V, Simic I, Ignjatovic VD, Petrovic N, Smiljanic Z, Zdravkovic V, Simovic S, Jovanovic D, Nesic J. Influence of Different beta-Blockers on Platelet Aggregation in Patients With Coronary Artery Disease on Dual Antiplatelet Therapy. J Cardiovasc Pharmacol Ther. 2016 Jan;21(1):44-52. doi: 10.1177/1074248415581175. Epub 2015 Apr 13.
Results Reference
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Effects of Beta-blockade on Platelet Aggregation in Acute Coronary Syndrome

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