NCT02809820

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

7 months

First QC Date

June 20, 2016

Last Update Submit

March 15, 2022

Conditions

Acute Coronary Syndrome

Keywords

ACSBeta Blockersplatelet aggregationlight transmission aggregometryBeta-Adrenergic Blockers

Outcome Measures

Primary Outcomes (1)

  • Platelet aggregation

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

    30 days

Secondary Outcomes (2)

  • 30-days platelet aggregation

    30 days

  • 30-days clinical events

    30 days

Study Arms (2)

Carvedilol

ACTIVE COMPARATOR

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

Drug: Carvedilol

Metoprolol

ACTIVE COMPARATOR

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

Drug: Metoprolol

Interventions

CarvedilolDRUG

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

Also known as: Selective beta-blocker
Carvedilol
MetoprololDRUG

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

Also known as: Non Selective beta-blocker
Metoprolol

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute Coronary Syndrome
  • Current dual anti platelet treatment with acetylsalicylic acid and Ticagrelor

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federico II University of Naples

Naples, 80131, Italy

Location

Related Publications (2)

  • 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.

    PMID: 24730697BACKGROUND

  • 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.

    PMID: 25868659BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

CarvedilolMetoprolol

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeterocyclic Compounds, 3-RingPhenoxypropanolamines

Study Officials

  • Giovanni Esposito, MD PhD

    Federico II University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 20, 2016

First Posted

June 22, 2016

Study Start

May 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 31, 2022

Record last verified: 2022-03

Locations

IT(1)