Effects of Beta-blockade on Platelet Aggregation in Acute Coronary Syndrome

NCT ID: NCT02809820

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Carvedilol

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

Group Type ACTIVE_COMPARATOR

Carvedilol

Intervention Type DRUG

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

Metoprolol

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

Group Type ACTIVE_COMPARATOR

Metoprolol

Intervention Type DRUG

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

Interventions

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Carvedilol

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

Intervention Type DRUG

Metoprolol

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

Intervention Type DRUG

Other Intervention Names

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Selective beta-blocker Non Selective beta-blocker

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Giovanni Esposito

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giovanni Esposito, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Federico II University

Locations

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Federico II University of Naples

Naples, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 24730697 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25868659 (View on PubMed)

Other Identifiers

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CE-9/14

Identifier Type: -

Identifier Source: org_study_id

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